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FS-1502 Versus T-DM1 for HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Investigational drug: Recombinant Anti-HER2 Humanized Monoclonal Antibody - Monomethyl Auristatin F Conjugates for Injection (FS-1502)
Control drug: Trastuzumab emtansine (Kadcyla, T-DM1)
Sponsored by
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:Subjects are eligible to be included in the study only if they meet all of the following criteria: Male or female age ≥ 18; Histologically or cytologically confirmed HER2-positive unresectable locally advanced or metastatic breast cancer; Prior treatment with trastuzumabs and taxanes in the adjuvant therapy, neoadjuvant therapy, or advanced treatment phases; ≥ 1 and ≤ 3 previous lines of therapy against locally advanced or metastatic diseases, if PD occurring during adjuvant therapy/neoadjuvant therapy and within 12 months after treatment can be taken as one line of therapy; Tissue samples qualified by the central laboratory for HER2 detection are available, and HER2 is confirmed positive by the pathology test in the central laboratory: Immunohistochemistry (IHC) 3+, or IHC2+ and fluorescence in situ hybridization (FISH)+ as the basis for inclusion; ECOG score at 0 or 1; Expected survival ≥ 12 weeks; Adequate organ and bone marrow functions: absolute neutrophil count [ANC] ≥1.0×10^9/L (no use of granulocyte-colony-stimulating factor (G-CSF) within 7 days); hemoglobin (HGB) ≥ 90 g/L (no red blood cell transfusion within 14 days); platelet count (PLT) ≥ 100×10^9/L (no use of platelet-elevating drugs within 7 days, no platelet transfusion within 14 days); total serum bilirubin (TSB) ≤ 1.5 × upper limit of normal (ULN) or ≤ 3.0 × ULN for patients with Gilbert syndrome; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN; for patients with liver metastases, AST and ALT ≤ 5×ULN; creatinine clearance ≥ 50 mL/min (calculated by Cockroft-Gault formula); blood potassium ≥3.5 mmol/L; albumin ≥ 3 g/dL; left ventricular ejection fraction (LVEF) >50%; urine protein ≤1+ or 24h urine protein quantification <1.0 g; At least one non-intracranial evaluable lesion as assessed by RECIST 1.1; Female patients of childbearing potential must agree to take highly effective contraceptive measures or avoid sexual intercourse during and after the study and within at least 3 months after the last dose of FS-1502 and within at least 7 months after the last dose of T-DM1. Male patients must agree to avoid sexual intercourse, or they and/or any female partners of childbearing potential must take a medically acceptable and effective contraceptive measure, such as double barrier methods, condoms, oral or injectable contraceptives, intra-uterine devices during and after the study and within at least 3 months after the last dose of FS-1502 or within at least 4 months after the last dose of T-DM1; Be able to understand and voluntarily sign the written Informed Consent Form (ICF). Exclusion Criteria: Patients that meet any of the following conditions shall not be included in this clinical study: Patients who have received chemotherapy, small molecule targeted drug therapy, endocrinotherapy,radiotherapy, etc. within 14 days or 5 half-lives (whichever is shorter) before administration or who have received major surgical treatment and tumor immunotherapy within 4 weeks before administration or who have received large molecule monoclonal antibody drugs for cancer treatment within 21 days before administration. Patients who have participated in other clinical studies within 4 weeks or 5 half-lives of the drug (whichever is shorter) before administration. Patients who have been previously treated with anti-HER2 ADCs for metastatic diseases. Patients with known hypersensitivity or delayed type hypersensitivity to certain ingredients of T-DM1 or similar drugs, or with known contraindications for the use of T-DM1. Patients with pia maters, spinal cords, brainstem and brain parenchymal metastases; such patients are allowed to be enrolled if all of the following conditions are met: Patients who have received local treatment and the lesions are stable for more than 6 months; Patients who have no clinical symptoms and don't need glucocorticoid therapy or other dehydration treatment, and have a stable dose of an antiepileptic drug, if applicable. Patients with a large quantity of clinically uncontrolled pleural effusion, pericardial effusion, or ascites (within 2 weeks prior to the first dose). Unresolved toxic reactions from previous anti-tumor therapy (> NCI-CTCAE 5.0 Grade 1); however, alopecia, neurotoxicity or other toxicity that has converted to chronic and returned to NCI-CTCAE 5.0 Grade ≤ 2, and does not affect the safety of the patient as assessed by the Investigator are allowed to be enrolled. History of non-infectious interstitial lung disease (ILD) / pneumonia, current ILD / pneumonia, or imaging suggestive of suspected moderate-severe ILD / pneumonia at screening. Subjects with corneal epithelial lesions (except mild punctate keratopathy), or other ocular diseases that affect the evaluation of ocular toxicity after the investigational product administration, or unwilling to stop wearing corneal contact lenses during the study. Patients on medications that prolong the QTc interval (mainly Classes Ia, Ic, III anti- arrhythmia medications) or with risk factors for prolonging the QTc interval, such as uncorrectable hypokalemia, inherited long QT syndrome; potential medications for prolonging the QTc interval are presented in Appendix 7. Cardiac function and diseases that meet one of the following conditions: Mean QTc > 450 ms for males and mean QTc > 470 ms for females averaged from 3 results of 12-lead ECG measurements using the QTcF formula of the ECG instrument at the study site during the screening period; New York Heart Association (NYHA) Functional Classification ≥ Class 2 congestive heart failure; Clinically significant arrhythmia (Grade ≥ 2); History of myocardial infarction or severe arteriovenous thrombotic events within 6 months. Pregnant or breastfeeding women. Known hypersensitivity to any excipients of FS-1502. Active infection requiring systemic therapy. Active hepatitis B (positive for HBV surface antigen and detected with HBV DNA > 1000 IU/mL or meeting the diagnostic criteria for active hepatitis B infection at the study site) or hepatitis C (positive for HCV RNA) and human immunodeficiency viral infection (HIV positive). Any other malignancy diagnosed within 5 years prior to the study, except for early malignancies (carcinoma in situ) that have undergone radical treatment, such as adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ. Any other diseases or conditions considered clinically significant by the investigator that could affect protocol compliance or affect the patient's ability to sign the ICF.

Sites / Locations

  • The first affiliated hospital of bengbu medical collegeRecruiting
  • Anhui Provincial Cancer HospitalRecruiting
  • Chinese People's Liberation Army General Hospital fifth Medical Center South wardRecruiting
  • Peking University People's HospitalRecruiting
  • Affiliated Cancer Hospital of Chongqing UniversityRecruiting
  • Chinese People's Liberation Army Army Special Medical CenterRecruiting
  • Fujian Cancer HospitalRecruiting
  • Fujian Medical University Union HospitalRecruiting
  • The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation ArmyRecruiting
  • The first affiliated hospital of xiamen universityRecruiting
  • The first Hospital of lanzhou UniversityRecruiting
  • Guangdong Provincial People's HospitalRecruiting
  • Sun Yat-sen University Cancer CenterRecruiting
  • The First Affiliated Hospital,Sun Yat-sen UniversityRecruiting
  • Shantou University School of Medicine Affiliated Cancer HospitalRecruiting
  • Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen CenterRecruiting
  • Guangxi Medical Univesity Cancer HospitalRecruiting
  • The First Afeliated Hospital of Guangxi Medical UniversityRecruiting
  • Affiliated Hospital of Hebei UniversityRecruiting
  • Cangzhou Central HospitalRecruiting
  • The Fourth Hospital of Hebei Medical UniversityRecruiting
  • Harbin Medical University Cancer HospitalRecruiting
  • AnYang Cancer HospitalRecruiting
  • The First Affiliated Hospital of Xinxiang Medical UniversityRecruiting
  • Henan Provincial People's HospitalRecruiting
  • Renmin Hospital Of Wuhan UniversityRecruiting
  • Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
  • Zhongnan Hospital of Wuhan UniversityRecruiting
  • Xiangyang Central HospitalRecruiting
  • The Second Xiangya Hospital, Central South UniversityRecruiting
  • Chenzhou No.1 People's HospitalRecruiting
  • The Central Hospital of YongzhouRecruiting
  • Jiangsu Cancer HospitalRecruiting
  • Jiangsu Province HospitalRecruiting
  • The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
  • Nanchang People's HospitalRecruiting
  • First Hospital of Jilin UniversityRecruiting
  • Jilin Cancer HospitalRecruiting
  • The Second Affiliated Hospital of Dalian Medical UniversityRecruiting
  • Liaoning cancer hospital & institute
  • The first hospital of china medical universityRecruiting
  • General Hospital of Ningxia Medical UniversityRecruiting
  • Shandong First Medical University and Shandong Academy of Medical Sciences Shandong Cancer Hospital instituteRecruiting
  • Affiliated Hospital of Jining Medical UniversityRecruiting
  • Linyi Cancer HospitalRecruiting
  • Shanxi Cancer HospitalRecruiting
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
  • West China Hospital,Sichuan UniversityRecruiting
  • Affiliated Hospital of Southwest Medical UniversityRecruiting
  • Neijiang Second People's HospitalRecruiting
  • TianJin Medical university Cancer Institute & HospitalRecruiting
  • Yunnan Cancer HospitalRecruiting
  • The Second Affiliated Hospital Zhejiang University School of MedicineRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
  • Henan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FS-1502

Trastuzumab Emtansine (T-DM1)

Arm Description

Experimental: FS-1502 Dosage form: lyophilized powder Specification: 30 mg/vial Dose: 2.3 mg/kg, once every 3 weeks, 21 days as a cycle; Method of administration: intravenous drip.

Active Comparator: Trastuzumab Emtansine (T-DM1) Trade name: Kadcyla Dosage form: lyophilized powder Specification: 100 mg/vial Dose: 3.6 mg/kg, once every 3 weeks, 21 days as a cycle; Method of administration: intravenous drip (this drug has been approved for marketing. Please refer to the package insert for details).

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) Based on Independent Central Review (ICR) in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.
Progression-free survival (PFS) by ICR was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.

Secondary Outcome Measures

Overall Survival (OS) in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.
Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause.
Objective Response Rate (ORR) Based on ICR and Investigator Assessment in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.
Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by ICR and investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR is reported.
Disease control rate (DCR) Based on ICR and Investigator Assessment in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.
DCR confirmed by IRC or investigator evaluation is defined as the proportion of patients with objective remission (CR or PR) or stable disease (SD) confirmed by IRC or investigator.
Clinical benefit rate (CBR) Based on ICR and Investigator Assessment in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.
CBR confirmed by IRC or investigator evaluation is defined as the proportion of patients with confirmed CR, PR and SD lasting ≥ 24 weeks evaluated by IRC or investigator according to RECIST version 1.1.
Duration of overall response (DOR) Based on ICR and Investigator Assessment in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.
Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DOR in participants with confirmed CR/PR based on BICR and investigator assessment is reported.
Progression-Free Survival (PFS) Based on Investigator Assessment in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.
Progression-free survival (PFS) by investigator assessment was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
Treatment-emergent adverse events (TEAEs).
Type and frequency of treatment-emergent adverse events (TEAEs) with toxicity grades evaluated according to the National Cancer Institute-Common Toxicity Criteria Adverse Event (NCI-CTCAE) version 5.0.

Full Information

First Posted
February 13, 2023
Last Updated
August 31, 2023
Sponsor
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05755048
Brief Title
FS-1502 Versus T-DM1 for HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
Official Title
A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study to Compare the Efficacy and Safety of FS-1502 Versus T-DM1 in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
July 30, 2025 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of FS-1502 versus T-DM1 in HER2-positive, unresectable locally advanced or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
Detailed Description
This study is a multicenter, open-label, randomized controlled phase III clinical study to compare the efficacy and safety of FS-1502 versus T-DM1 in patients with HER2-positive unresectable locally advanced or metastatic breast cancer. Patients who meet the inclusion and exclusion criteria will be randomized into the test group (FS-1502) or control group (T-DM1) in a 1:1 ratio. Patients in the test group will receive FS-1502 2.3 mg/kg, and those in the control group will receive T-DM1 3.6 mg/kg, by intravenous drip every 3 weeks. Patients will be treated until disease progression (PD), intolerable toxicity, withdrawal of consent, death, or other protocol-specified reasons. According to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1), tumor assessment will be performed every 6 weeks (± 7 days) for the first 12 months and every 12 weeks (± 7 days) after 12 months until PD, withdrawal of consent, or death. Efficacy evaluation will be performed by the investigator and the Independent Review Committee (IRC), respectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
314 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FS-1502
Arm Type
Experimental
Arm Description
Experimental: FS-1502 Dosage form: lyophilized powder Specification: 30 mg/vial Dose: 2.3 mg/kg, once every 3 weeks, 21 days as a cycle; Method of administration: intravenous drip.
Arm Title
Trastuzumab Emtansine (T-DM1)
Arm Type
Active Comparator
Arm Description
Active Comparator: Trastuzumab Emtansine (T-DM1) Trade name: Kadcyla Dosage form: lyophilized powder Specification: 100 mg/vial Dose: 3.6 mg/kg, once every 3 weeks, 21 days as a cycle; Method of administration: intravenous drip (this drug has been approved for marketing. Please refer to the package insert for details).
Intervention Type
Biological
Intervention Name(s)
Investigational drug: Recombinant Anti-HER2 Humanized Monoclonal Antibody - Monomethyl Auristatin F Conjugates for Injection (FS-1502)
Intervention Description
Experimental: FS-1502 Dosage form: lyophilized powder Specification: 30 mg/vial Dose: 2.3 mg/kg, once every 3 weeks, 21 days as a cycle; Method of administration: intravenous drip.
Intervention Type
Biological
Intervention Name(s)
Control drug: Trastuzumab emtansine (Kadcyla, T-DM1)
Intervention Description
Active Comparator: Trastuzumab Emtansine (T-DM1) Trade name: Kadcyla Dosage form: lyophilized powder Specification: 100 mg/vial Dose: 3.6 mg/kg, once every 3 weeks, 21 days as a cycle; Method of administration: intravenous drip (this drug has been approved for marketing. Please refer to the package insert for details).
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) Based on Independent Central Review (ICR) in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.
Description
Progression-free survival (PFS) by ICR was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
Time Frame
Up to 28 months.
Secondary Outcome Measure Information:
Title
Overall Survival (OS) in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.
Description
Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause.
Time Frame
Up to 28 months.
Title
Objective Response Rate (ORR) Based on ICR and Investigator Assessment in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.
Description
Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by ICR and investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR is reported.
Time Frame
Up to 28 months.
Title
Disease control rate (DCR) Based on ICR and Investigator Assessment in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.
Description
DCR confirmed by IRC or investigator evaluation is defined as the proportion of patients with objective remission (CR or PR) or stable disease (SD) confirmed by IRC or investigator.
Time Frame
Up to 28 months.
Title
Clinical benefit rate (CBR) Based on ICR and Investigator Assessment in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.
Description
CBR confirmed by IRC or investigator evaluation is defined as the proportion of patients with confirmed CR, PR and SD lasting ≥ 24 weeks evaluated by IRC or investigator according to RECIST version 1.1.
Time Frame
Up to 28 months.
Title
Duration of overall response (DOR) Based on ICR and Investigator Assessment in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.
Description
Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DOR in participants with confirmed CR/PR based on BICR and investigator assessment is reported.
Time Frame
Up to 28 months.
Title
Progression-Free Survival (PFS) Based on Investigator Assessment in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.
Description
Progression-free survival (PFS) by investigator assessment was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
Time Frame
Up to 28 months.
Title
Treatment-emergent adverse events (TEAEs).
Description
Type and frequency of treatment-emergent adverse events (TEAEs) with toxicity grades evaluated according to the National Cancer Institute-Common Toxicity Criteria Adverse Event (NCI-CTCAE) version 5.0.
Time Frame
Up to 28 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Subjects are eligible to be included in the study only if they meet all of the following criteria: Male or female age ≥ 18; Histologically or cytologically confirmed HER2-positive unresectable locally advanced or metastatic breast cancer; Prior treatment with trastuzumabs and taxanes in the adjuvant therapy, neoadjuvant therapy, or advanced treatment phases; ≥ 1 and ≤ 3 previous lines of therapy against locally advanced or metastatic diseases, if PD occurring during adjuvant therapy/neoadjuvant therapy and within 12 months after treatment can be taken as one line of therapy; Tissue samples qualified by the central laboratory for HER2 detection are available, and HER2 is confirmed positive by the pathology test in the central laboratory: Immunohistochemistry (IHC) 3+, or IHC2+ and fluorescence in situ hybridization (FISH)+ as the basis for inclusion; ECOG score at 0 or 1; Expected survival ≥ 12 weeks; Adequate organ and bone marrow functions: absolute neutrophil count [ANC] ≥1.0×10^9/L (no use of granulocyte-colony-stimulating factor (G-CSF) within 7 days); hemoglobin (HGB) ≥ 90 g/L (no red blood cell transfusion within 14 days); platelet count (PLT) ≥ 100×10^9/L (no use of platelet-elevating drugs within 7 days, no platelet transfusion within 14 days); total serum bilirubin (TSB) ≤ 1.5 × upper limit of normal (ULN) or ≤ 3.0 × ULN for patients with Gilbert syndrome; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN; for patients with liver metastases, AST and ALT ≤ 5×ULN; creatinine clearance ≥ 50 mL/min (calculated by Cockroft-Gault formula); blood potassium ≥3.5 mmol/L; albumin ≥ 3 g/dL; left ventricular ejection fraction (LVEF) >50%; urine protein ≤1+ or 24h urine protein quantification <1.0 g; At least one non-intracranial evaluable lesion as assessed by RECIST 1.1; Female patients of childbearing potential must agree to take highly effective contraceptive measures or avoid sexual intercourse during and after the study and within at least 3 months after the last dose of FS-1502 and within at least 7 months after the last dose of T-DM1. Male patients must agree to avoid sexual intercourse, or they and/or any female partners of childbearing potential must take a medically acceptable and effective contraceptive measure, such as double barrier methods, condoms, oral or injectable contraceptives, intra-uterine devices during and after the study and within at least 3 months after the last dose of FS-1502 or within at least 4 months after the last dose of T-DM1; Be able to understand and voluntarily sign the written Informed Consent Form (ICF). Exclusion Criteria: Patients that meet any of the following conditions shall not be included in this clinical study: Patients who have received chemotherapy, small molecule targeted drug therapy, endocrinotherapy,radiotherapy, etc. within 14 days or 5 half-lives (whichever is shorter) before administration or who have received major surgical treatment and tumor immunotherapy within 4 weeks before administration or who have received large molecule monoclonal antibody drugs for cancer treatment within 21 days before administration. Patients who have participated in other clinical studies within 4 weeks or 5 half-lives of the drug (whichever is shorter) before administration. Patients who have been previously treated with anti-HER2 ADCs for metastatic diseases. Patients with known hypersensitivity or delayed type hypersensitivity to certain ingredients of T-DM1 or similar drugs, or with known contraindications for the use of T-DM1. Patients with pia maters, spinal cords, brainstem and brain parenchymal metastases; such patients are allowed to be enrolled if all of the following conditions are met: Patients who have received local treatment and the lesions are stable for more than 6 months; Patients who have no clinical symptoms and don't need glucocorticoid therapy or other dehydration treatment, and have a stable dose of an antiepileptic drug, if applicable. Patients with a large quantity of clinically uncontrolled pleural effusion, pericardial effusion, or ascites (within 2 weeks prior to the first dose). Unresolved toxic reactions from previous anti-tumor therapy (> NCI-CTCAE 5.0 Grade 1); however, alopecia, neurotoxicity or other toxicity that has converted to chronic and returned to NCI-CTCAE 5.0 Grade ≤ 2, and does not affect the safety of the patient as assessed by the Investigator are allowed to be enrolled. History of non-infectious interstitial lung disease (ILD) / pneumonia, current ILD / pneumonia, or imaging suggestive of suspected moderate-severe ILD / pneumonia at screening. Subjects with corneal epithelial lesions (except mild punctate keratopathy), or other ocular diseases that affect the evaluation of ocular toxicity after the investigational product administration, or unwilling to stop wearing corneal contact lenses during the study. Patients on medications that prolong the QTc interval (mainly Classes Ia, Ic, III anti- arrhythmia medications) or with risk factors for prolonging the QTc interval, such as uncorrectable hypokalemia, inherited long QT syndrome; potential medications for prolonging the QTc interval are presented in Appendix 7. Cardiac function and diseases that meet one of the following conditions: Mean QTc > 450 ms for males and mean QTc > 470 ms for females averaged from 3 results of 12-lead ECG measurements using the QTcF formula of the ECG instrument at the study site during the screening period; New York Heart Association (NYHA) Functional Classification ≥ Class 2 congestive heart failure; Clinically significant arrhythmia (Grade ≥ 2); History of myocardial infarction or severe arteriovenous thrombotic events within 6 months. Pregnant or breastfeeding women. Known hypersensitivity to any excipients of FS-1502. Active infection requiring systemic therapy. Active hepatitis B (positive for HBV surface antigen and detected with HBV DNA > 1000 IU/mL or meeting the diagnostic criteria for active hepatitis B infection at the study site) or hepatitis C (positive for HCV RNA) and human immunodeficiency viral infection (HIV positive). Any other malignancy diagnosed within 5 years prior to the study, except for early malignancies (carcinoma in situ) that have undergone radical treatment, such as adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ. Any other diseases or conditions considered clinically significant by the investigator that could affect protocol compliance or affect the patient's ability to sign the ICF.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Binghe Xu, MD
Phone
13501028690
Email
xubingheBM@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binghe Xu, MD
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first affiliated hospital of bengbu medical college
City
Bengbu
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gongsheng Jin, MD
Phone
13095520028
Email
Jgs2007@qq.com
First Name & Middle Initial & Last Name & Degree
Gongsheng Jin, MD
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changlu Hu, MD
Phone
13955116061
Email
13955116061@139.com
First Name & Middle Initial & Last Name & Degree
Changlu Hu, MD
Facility Name
Chinese People's Liberation Army General Hospital fifth Medical Center South ward
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Wang, MD
Phone
13910928773
Email
wangtaodoc@163.com
First Name & Middle Initial & Last Name & Degree
Tao Wang, MD
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu Wang, MD
Phone
13801080201
Email
dr.wangshu@263.net
First Name & Middle Initial & Last Name & Degree
Shu Wang, MD
Facility Name
Affiliated Cancer Hospital of Chongqing University
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Zhou, MD
Phone
13452987363
Email
zhouxin000017@163.com
First Name & Middle Initial & Last Name & Degree
Xin Zhou, MD
Facility Name
Chinese People's Liberation Army Army Special Medical Center
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinlu Shan, MD
Phone
18623026302
Email
lulu@sina.com
First Name & Middle Initial & Last Name & Degree
Jinlu Shan, MD
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YueHua Wang, MD
Phone
13995777482
Email
510839835@qq.com
First Name & Middle Initial & Last Name & Degree
YueHua Wang, MD
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyan Lin, MD
Phone
139 5048 2366
Email
13950482366@qq.com
First Name & Middle Initial & Last Name & Degree
Xiaoyan Lin, MD
Facility Name
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Chen, MD
Phone
13705045925
Email
cxifuzhou@163.com
First Name & Middle Initial & Last Name & Degree
Xi Chen, MD
Facility Name
The first affiliated hospital of xiamen university
City
Xiamen
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhong Ouyang, doctor
Phone
18205962909
Email
xmdxdyyyrxkoyz@163.com
First Name & Middle Initial & Last Name & Degree
Zhong Ouyang, doctor
Facility Name
The first Hospital of lanzhou University
City
Lanzhou
State/Province
Gansu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoling Ling, MD
Phone
18693165668
Email
lingxiaolingedu@163.com
First Name & Middle Initial & Last Name & Degree
Xiaoling Ling, MD
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kun Wang, MD
Phone
13922118086
Email
gzwangkun@126.com
First Name & Middle Initial & Last Name & Degree
Kun Wang, MD
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanxia Shi, MD
Phone
13609058827
Email
shiyx@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Yanxia Shi, MD
Facility Name
The First Affiliated Hospital,Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Lin, MD
Phone
130 7687 3871
Email
frostlin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ying Lin, MD
Facility Name
Shantou University School of Medicine Affiliated Cancer Hospital
City
Shantou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
De Zeng, MD
Phone
13750418885
Email
alexzengde@163.com
First Name & Middle Initial & Last Name & Degree
De Zeng, MD
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center
City
Shenzhen
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caiwen Du, MD
Phone
135 5631 6023
Email
dusumc@aliyun.com
First Name & Middle Initial & Last Name & Degree
Caiwen Du, MD
Facility Name
Guangxi Medical Univesity Cancer Hospital
City
Nanning
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weimin Xie, MD
Phone
13907861028
Email
dd.xie@qq.com
First Name & Middle Initial & Last Name & Degree
Weimin Xie, MD
Facility Name
The First Afeliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jincai Zhong, M.M.
Phone
13907719863
Email
1093301007@qq.com
First Name & Middle Initial & Last Name & Degree
Jincai Zhong, M.M.
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Yang, MD
Phone
18603120729
Email
docyh@163.com
First Name & Middle Initial & Last Name & Degree
Hua Yang, MD
Facility Name
Cangzhou Central Hospital
City
Cangzhou
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guozhong Cui, MD
Phone
13315777876
Email
916291826@qq.com
First Name & Middle Initial & Last Name & Degree
Guozhong Cui, MD
Facility Name
The Fourth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunjiang Liu, doctor
Phone
13703297890
Email
lyj818326@126.com
First Name & Middle Initial & Last Name & Degree
Yunjiang Liu, doctor
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qing Yuan Zhang, MD
Phone
13313612989
Email
ns86298333@163.com
First Name & Middle Initial & Last Name & Degree
Qing Yuan Zhang, MD
Facility Name
AnYang Cancer Hospital
City
AnYang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Xia, MD
Phone
15890750990
Email
15890750990@126.com
First Name & Middle Initial & Last Name & Degree
Jin Xia, MD
Facility Name
The First Affiliated Hospital of Xinxiang Medical University
City
Xinxiang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Lu, MD
Phone
18567569821
Email
lupingdoctor@126.com
First Name & Middle Initial & Last Name & Degree
Ping Lu, MD
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuangxin Lu, MD
Phone
15093406297
Email
lcxin618@163.com
First Name & Middle Initial & Last Name & Degree
Chuangxin Lu, MD
Facility Name
Renmin Hospital Of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Yao, MD
Phone
13667174996
Email
yaofengrmh@163.com
First Name & Middle Initial & Last Name & Degree
Feng Yao, MD
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yanxia Zhao, MD
Phone
13407192551
Email
sophia7781@126.com
First Name & Middle Initial & Last Name & Degree
yanxia Zhao, MD
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HaiJun Yu, MD
Phone
13971665181
Email
doctoryhj@126.com
First Name & Middle Initial & Last Name & Degree
HaiJun Yu, MD
Facility Name
Xiangyang Central Hospital
City
Xiangyang
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
WeiWei Huang, MD
Phone
13763893896
Email
huangstudenth@163.com
First Name & Middle Initial & Last Name & Degree
WeiWei Huang, MD
Facility Name
The Second Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenjun Yi, Doctor
Phone
18608403318
Email
yiwenjun@csu.edu.cn
First Name & Middle Initial & Last Name & Degree
Wenjun Yi, Doctor
Facility Name
Chenzhou No.1 People's Hospital
City
Chenzhou
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hailong Liu, MD
Phone
18973575117
Email
827362121@qq.com
First Name & Middle Initial & Last Name & Degree
Hailong Liu, MD
Facility Name
The Central Hospital of Yongzhou
City
Yongzhou
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sijuan Ding, MM
Phone
13574624257
Email
874663807@qq.com
First Name & Middle Initial & Last Name & Degree
Sijuan Ding, MM
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jifeng Feng, MD
Phone
13901581264
Email
fjif@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Jifeng Feng, MD
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongmei Yin, MD
Phone
13951842727
Email
ym.yin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yongmei Yin, MD
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tian You Tang, MB
Phone
13775980765
Email
tty912@163.com
First Name & Middle Initial & Last Name & Degree
Tian You Tang, MB
Facility Name
Nanchang People's Hospital
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenyan Chen, MB
Phone
18679168977
Email
chenwenyannc2013@163.com
First Name & Middle Initial & Last Name & Degree
Wenyan Chen, MB
Facility Name
First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiuwei Cui, MD
Phone
15843073215
Email
jdyycjw@163.com
First Name & Middle Initial & Last Name & Degree
Jiuwei Cui, MD
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Cheng, MD
Phone
0431-80596315
Email
jl.cheng@163.com
First Name & Middle Initial & Last Name & Degree
Ying Cheng, MD
Facility Name
The Second Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ma Li, MD
Phone
17709873580
Email
dyeyliman@sohu.com
First Name & Middle Initial & Last Name & Degree
Ma Li, MD
Facility Name
Liaoning cancer hospital & institute
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Sun, MD
Phone
13940404526
Email
lnzlrxnsy@163.com
First Name & Middle Initial & Last Name & Degree
Tao Sun, MD
Facility Name
The first hospital of china medical university
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuee Teng, MD
Phone
13591639797
Email
tengyuee0517@163.com
First Name & Middle Initial & Last Name & Degree
Yuee Teng, MD
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinlan Liu, MD
Phone
13709577339
Email
liuxinlan@csco.ac.cn
First Name & Middle Initial & Last Name & Degree
Xinlan Liu, MD
Facility Name
Shandong First Medical University and Shandong Academy of Medical Sciences Shandong Cancer Hospital institute
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huihui Li, MD
Phone
15553103209
Email
15553103209@163.com
First Name & Middle Initial & Last Name & Degree
Huihui Li, MD
Facility Name
Affiliated Hospital of Jining Medical University
City
Jining
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changping Shan, MD
Phone
18678766865
Email
scp9933@163.com
First Name & Middle Initial & Last Name & Degree
Changping Shan, MD
Facility Name
Linyi Cancer Hospital
City
Linyi
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingfen Wang, MD
Phone
15963976026
Email
15963976026@wetrial.com
First Name & Middle Initial & Last Name & Degree
Jingfen Wang, MD
Facility Name
Shanxi Cancer Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuguo Tian, MD
Phone
13934559988
Email
2205473988@qq.com
First Name & Middle Initial & Last Name & Degree
Fuguo Tian, MD
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xian
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Yang, MD
Phone
18991232383
Email
1473106133@qq.com
First Name & Middle Initial & Last Name & Degree
Jin Yang, MD
Facility Name
West China Hospital,Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YanHui Liu, MD
Phone
18980601509
Email
827005432@qq.com
First Name & Middle Initial & Last Name & Degree
YanHui Liu, MD
Facility Name
Affiliated Hospital of Southwest Medical University
City
Luzhou
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijia He, MD
Phone
13619042857
Email
908380148@qq.com
First Name & Middle Initial & Last Name & Degree
Lijia He, MD
Facility Name
Neijiang Second People's Hospital
City
Neijiang
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xujuan Wang, MD
Phone
13696038558
Email
61132803@qq.com
First Name & Middle Initial & Last Name & Degree
Xujuan Wang, MD
Facility Name
TianJin Medical university Cancer Institute & Hospital
City
TianJin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongsheng Tong, MD
Phone
18622221181
Email
18622221181@163.COM
First Name & Middle Initial & Last Name & Degree
Zhongsheng Tong, MD
Facility Name
Yunnan Cancer Hospital
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianyun Nie, MD
Phone
13608815577
Email
niejianyungcp@163.com
First Name & Middle Initial & Last Name & Degree
Jianyun Nie, MD
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Huang, MD
Phone
139 5812 3068
Email
hjys@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Jian Huang, MD
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojia Wang, MD
Phone
13906500190
Email
wxiaojia0803@163.com
First Name & Middle Initial & Last Name & Degree
Xiaojia Wang, MD
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
OuChen Wang, MD
Phone
13957706099
Email
woc099@163.com
First Name & Middle Initial & Last Name & Degree
OuChen Wang, MD
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
ZHenan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Yan, dotocr
Phone
15713857388
Email
ym200678@126.com
First Name & Middle Initial & Last Name & Degree
Min Yan, dotocr

12. IPD Sharing Statement

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FS-1502 Versus T-DM1 for HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

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