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Safety and Efficacy of SCT200 in Patients With Relapsed or Metastatic Triple Receptor Negative Breast Cancer

Primary Purpose

Triple Negative Breast Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SCT200
Sponsored by
Sinocelltech Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple Negative Breast Neoplasms focused on measuring Triple Negative Breast Neoplasms, Breast Neoplasms, Neoplasms by Site, Neoplasms, Epidermal growth factor receptor, EGFR, SCT200

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Able to provide written informed consent and can understand and comply with the requirements of the study;
  • Women from 18 to 75 years old;
  • Life expectancy of longer than 3 months ( clinical assessment);
  • With an Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
  • Histological or cytological diagnosis of relapsed/metastatic triple receptor negative breast cancer (TNBC).TNBC is defined negatively expression of estrogen(ER), progesterone(PR) and human epidermal receptor-2(HER2).If there is a pathology report of the metastasis, take the histopathology of the metastases as standard. Negative of ER and PR is defined as expression of ER,PR<1% of the tumor cells by immunohistochemistry (IHC). HER2-negative is defined as a score of 0 and 1+ by IHC, or IHC 2+ & fluorescent in situ hybridization (FISH)negative. If the ER2 test result is 0 or 1+ by IHC, FISH detection is optional, but the result must be negative.
  • Participants has received prior anthracyclines and/or taxanes in first-line therapy. Disease progressed after latest chemotherapy. For adjuvant therapy/neoadjuvant therapy, disease relapse or progression during treatment or within 6 months after treatment is considered as failure of standard therapy.
  • According to RECIST 1.1 , patients must have at least one measurable lesion that can be accurately assessed at baseline.
  • Adequate organ and marrow function as defined below:

Absolute neutrophil count (ANC) greater than/equal to 1.5×l09/L; Platelets greater than/equal to 75×109/L; Hemoglobin greater than/equal to 80g/L; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than/equal to 3 times ULN, or less than/equal to 5 times ULN if known liver metastases; Total bilirubin less than/equal to 1.5 within institutional limit of normal (ULN); Serum creatinine less than/equal to 1.5 times ULN; Electrolyte: magnesium greater than/equal to normal.

-Females: Post-menopausal, surgically sterile, non-pregnant and non-lactating.Women of childbearing potential must not be pregnant as assessed by a negative serum beta HCG test drawn upon admission to the hospital or up to 7 days prior to admission, and must agree to use adequate contraception (Oral contraceptives; intrauterine deviceshormonal; barrier method of birth control; abstinence) for the duration of study participation.and within 6 months after study.

Exclusion Criteria:

  • Patients who are allergic to analogue of SCT200 and/or its inactive ingredients;
  • Patient with active brain metastasis or indicated for symptomatic treatment for brain metastasis;
  • Subject receiving bisphosphonate or denosumab treatment for bone metastases was initiated within 28 days prior to study. (If the subject has received bisphosphonate or denosumab treatment prior to study and showing stable time less than 28 days,the subject is allowed to use it. Subjects who were enrolled in this study may start taking bisphosphonate or denosumab for bone metastases after the first assessment of the efficacy.
  • Patients with other primary malignancies, except cured of basal cell carcinoma skin cancer or carcinoma in situ of cervix;
  • Patients administrated EGFR target treatment including EGFR TKI agent or anti- EGFR monoclonal antibody;
  • Within 4 weeks, patients received anti-tumor drugs (such as chemotherapy, hormone therapy, immune therapy, the antibody therapy, radiotherapy) or research drugs, or patients with grade 2 or more adverse reaction caused by previous anti-tumor therapy(except alopecia or neurotoxicity grade 2 or less);
  • Patients are currently enrolled in other research devices or in research drugs, or less than 4 weeks from other research drugs or devices.
  • Patients received major surgery(such as need general anesthesia ) within 4 weeks , should recover from the injury associated with the surgery.
  • Patients treated with EPO, G-CSF or GM-CSF.
  • Patients who have clinically significant cardiovascular disease (defined as unstable angina pectoris, symptomatic congestive heart failure (NYHA, greater than II), uncontrollable severe arrhythmia); Patients occurred myocardial infarction within 6 months.
  • According to the investigator's judgment, patients have other coexisting severe and/or poorly controlled medical conditions (such as uncontrolled hypertension, uncontrolled diabetes, clotting/hemorrhagic disease, etc.).
  • Patients who have interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or CT or MRI reminder ILD .
  • Patients with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites);
  • Patients with serious psychological or psychiatric disorders which may affect subject compliance in this clinical study;
  • Pregnant or lactating women, or women who planned to be pregnant within 6 months of treatment;
  • Patients who were not willing to accept effective contraceptive measures (including male or female subjects) during treatment and within 6 months after treatment;
  • Patients with active hepatitis B or active hepatitis C, etc. (for patients with a history of hepatitis B, whether treated or not, HBV DNA ≥104 or ≥ 2000IU/ml, HCV RNA≥15IU/ml); HIV antibody positive (if there is no clinical evidence suggesting that there may be HIV infection, there is no need to detect);
  • Patients with uncontrolled active infections before enrollment 2 weeks (except simple urinary tract infection or upper respiratory tract infection);
  • Patients have alcohol or drug addiction;
  • Subjects who are considered unsuitable for participating in this study for various reasons at the discretion of the investigator,such as inability to comply with study and/or follow-up procedures;

Sites / Locations

  • Cancer Hospital Affiliated to Harbin Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SCT200

Arm Description

Initially, 6.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 8.0mg/kg of SCT200 will be administered every two weeks until disease progression.

Outcomes

Primary Outcome Measures

Objective response rate (ORR)
ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment.

Secondary Outcome Measures

Adverse events (AEs)
AE are assessed according to NCI CTCAE v4.03.
Progress Free Survival ( PFS)
PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 criteria.
Duration of response (DOR)
DOR is defined as time from the date when a patient first meets the criteria for CR or PR according to RECIST v1.1, until the date that progressive disease (PD) is objectively documented or death, whichever occurs first.
Disease control rate (DCR)
The achievement of any a stable response(SD), partial response (PR) or complete response (CR), according to RECIST v1.1 criteria.
Time to Progression (TTP)
TTP is defined as the time from first dose of SCT200 until the date of first documentation of progressive disease (PD), according to RECIST v1.1 criteria.
Overall survival (OS)
OS is defined as time from first dose of SCT200 until the date of death from any cause.

Full Information

First Posted
September 29, 2018
Last Updated
September 29, 2018
Sponsor
Sinocelltech Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03692689
Brief Title
Safety and Efficacy of SCT200 in Patients With Relapsed or Metastatic Triple Receptor Negative Breast Cancer
Official Title
Recombinant Anti-EGFR Monoclonal Antibody(SCT200) in Patients With Relapsed or Metastatic Triple Receptor Negative Breast Cancer : a Phase Ⅱ, Open-label, Single-arm, Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 20, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinocelltech Ltd.

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR monoclonal antibody(SCT200)in patients with triple receptor negative breast cancer treated after failure of standard therapy (including Anthracyclines and/or Taxanes).
Detailed Description
This open label,single-arm multicenter phase II study is designed to evaluate Objective Response Rate (ORR) in advanced triple receptor negative breast cancer treated with anti-EGFR monoclonal antibody SCT200.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Neoplasms
Keywords
Triple Negative Breast Neoplasms, Breast Neoplasms, Neoplasms by Site, Neoplasms, Epidermal growth factor receptor, EGFR, SCT200

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SCT200
Arm Type
Experimental
Arm Description
Initially, 6.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 8.0mg/kg of SCT200 will be administered every two weeks until disease progression.
Intervention Type
Biological
Intervention Name(s)
SCT200
Intervention Description
Recombinant Anti-EGFR Monoclonal Antibody(SCT200)
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adverse events (AEs)
Description
AE are assessed according to NCI CTCAE v4.03.
Time Frame
1 year
Title
Progress Free Survival ( PFS)
Description
PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 criteria.
Time Frame
1 year
Title
Duration of response (DOR)
Description
DOR is defined as time from the date when a patient first meets the criteria for CR or PR according to RECIST v1.1, until the date that progressive disease (PD) is objectively documented or death, whichever occurs first.
Time Frame
1 year
Title
Disease control rate (DCR)
Description
The achievement of any a stable response(SD), partial response (PR) or complete response (CR), according to RECIST v1.1 criteria.
Time Frame
1 year
Title
Time to Progression (TTP)
Description
TTP is defined as the time from first dose of SCT200 until the date of first documentation of progressive disease (PD), according to RECIST v1.1 criteria.
Time Frame
1 year
Title
Overall survival (OS)
Description
OS is defined as time from first dose of SCT200 until the date of death from any cause.
Time Frame
1 year

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to provide written informed consent and can understand and comply with the requirements of the study; Women from 18 to 75 years old; Life expectancy of longer than 3 months ( clinical assessment); With an Eastern Cooperative Oncology Group (ECOG) performance status 0-2; Histological or cytological diagnosis of relapsed/metastatic triple receptor negative breast cancer (TNBC).TNBC is defined negatively expression of estrogen(ER), progesterone(PR) and human epidermal receptor-2(HER2).If there is a pathology report of the metastasis, take the histopathology of the metastases as standard. Negative of ER and PR is defined as expression of ER,PR<1% of the tumor cells by immunohistochemistry (IHC). HER2-negative is defined as a score of 0 and 1+ by IHC, or IHC 2+ & fluorescent in situ hybridization (FISH)negative. If the ER2 test result is 0 or 1+ by IHC, FISH detection is optional, but the result must be negative. Participants has received prior anthracyclines and/or taxanes in first-line therapy. Disease progressed after latest chemotherapy. For adjuvant therapy/neoadjuvant therapy, disease relapse or progression during treatment or within 6 months after treatment is considered as failure of standard therapy. According to RECIST 1.1 , patients must have at least one measurable lesion that can be accurately assessed at baseline. Adequate organ and marrow function as defined below: Absolute neutrophil count (ANC) greater than/equal to 1.5×l09/L; Platelets greater than/equal to 75×109/L; Hemoglobin greater than/equal to 80g/L; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than/equal to 3 times ULN, or less than/equal to 5 times ULN if known liver metastases; Total bilirubin less than/equal to 1.5 within institutional limit of normal (ULN); Serum creatinine less than/equal to 1.5 times ULN; Electrolyte: magnesium greater than/equal to normal. -Females: Post-menopausal, surgically sterile, non-pregnant and non-lactating.Women of childbearing potential must not be pregnant as assessed by a negative serum beta HCG test drawn upon admission to the hospital or up to 7 days prior to admission, and must agree to use adequate contraception (Oral contraceptives; intrauterine deviceshormonal; barrier method of birth control; abstinence) for the duration of study participation.and within 6 months after study. Exclusion Criteria: Patients who are allergic to analogue of SCT200 and/or its inactive ingredients; Patient with active brain metastasis or indicated for symptomatic treatment for brain metastasis; Subject receiving bisphosphonate or denosumab treatment for bone metastases was initiated within 28 days prior to study. (If the subject has received bisphosphonate or denosumab treatment prior to study and showing stable time less than 28 days,the subject is allowed to use it. Subjects who were enrolled in this study may start taking bisphosphonate or denosumab for bone metastases after the first assessment of the efficacy. Patients with other primary malignancies, except cured of basal cell carcinoma skin cancer or carcinoma in situ of cervix; Patients administrated EGFR target treatment including EGFR TKI agent or anti- EGFR monoclonal antibody; Within 4 weeks, patients received anti-tumor drugs (such as chemotherapy, hormone therapy, immune therapy, the antibody therapy, radiotherapy) or research drugs, or patients with grade 2 or more adverse reaction caused by previous anti-tumor therapy(except alopecia or neurotoxicity grade 2 or less); Patients are currently enrolled in other research devices or in research drugs, or less than 4 weeks from other research drugs or devices. Patients received major surgery(such as need general anesthesia ) within 4 weeks , should recover from the injury associated with the surgery. Patients treated with EPO, G-CSF or GM-CSF. Patients who have clinically significant cardiovascular disease (defined as unstable angina pectoris, symptomatic congestive heart failure (NYHA, greater than II), uncontrollable severe arrhythmia); Patients occurred myocardial infarction within 6 months. According to the investigator's judgment, patients have other coexisting severe and/or poorly controlled medical conditions (such as uncontrolled hypertension, uncontrolled diabetes, clotting/hemorrhagic disease, etc.). Patients who have interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or CT or MRI reminder ILD . Patients with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites); Patients with serious psychological or psychiatric disorders which may affect subject compliance in this clinical study; Pregnant or lactating women, or women who planned to be pregnant within 6 months of treatment; Patients who were not willing to accept effective contraceptive measures (including male or female subjects) during treatment and within 6 months after treatment; Patients with active hepatitis B or active hepatitis C, etc. (for patients with a history of hepatitis B, whether treated or not, HBV DNA ≥104 or ≥ 2000IU/ml, HCV RNA≥15IU/ml); HIV antibody positive (if there is no clinical evidence suggesting that there may be HIV infection, there is no need to detect); Patients with uncontrolled active infections before enrollment 2 weeks (except simple urinary tract infection or upper respiratory tract infection); Patients have alcohol or drug addiction; Subjects who are considered unsuitable for participating in this study for various reasons at the discretion of the investigator,such as inability to comply with study and/or follow-up procedures;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
qingyuan zhang, MD
Phone
0086-451-86298276
Email
sy86298276@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
qingyuan zhang, MD
Organizational Affiliation
Cancer Hospital Affiliated to Harbin Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital Affiliated to Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qingyuan zhang, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Efficacy of SCT200 in Patients With Relapsed or Metastatic Triple Receptor Negative Breast Cancer

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