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A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer

Primary Purpose

Non Small Cell Lung Cancer, Breast Cancer

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
YL202
Sponsored by
MediLink Therapeutics (Suzhou) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria: Informed of the trial before the start of the trial and voluntarily sign their name and date on the informed consent form Aged ≥18 years Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2 Adequate organ and bone marrow function Female patients of childbearing potential must agree to use a highly effective form of contraception and not donate, or retrieve for their own use, ova from the time of screening and throughout the study period, and for at least 6 months after the last dose of study drug. Male patients must agree to use a highly effective form of contraception and not freeze or donate sperm from the time of screening and throughout the study period, and for at least 6 months after the last dose of study drug. Life expectancy of ≥3 months Able and willing to comply with protocol visits and procedures For NSCLC patients: Have a histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC not amenable to curative surgery or radiation Have a documentation of an EGFR-activating mutation (exon 19 deletion or L858R) detected at diagnosis or thereafter Have documentation of disease progression on or after, or are intolerant to prior standard treatment regimens for locally advanced or metastatic disease. For BC patients: Have a histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic HR-positive and HER2-negative BC (per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines) Have documentation of disease progression on or after, or are intolerant to prior standard treatment regimens for locally advanced or metastatic disease. Have at least 1 measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Exclusion Criteria: Intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor, including but not limited to topotecan, irinotecan, and DXd (e.g., severe diarrhea) Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study Inadequate washout period for prior anticancer treatment before the first dose of study drug Undergone major surgery (not including diagnostic surgery) within 4 weeks before the first dose of study drug or expect major surgery during the study Prior allogeneic bone marrow transplantation or solid-organ transplantation Received systemic steroids (>10 mg/day of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks before the first dose of study drug. The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) Systemic steroids at physiological doses as replacement therapy (e.g., physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication) Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study A history of leptomeningeal carcinomatosis Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 2 weeks before the first dose of study drug Uncontrolled or clinically significant cardiovascular disease. A history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that requires steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening Clinically significant concomitant pulmonary disease. Clinically significant corneal disease Have a diagnosis of Gilbert's syndrome Uncontrolled third-space fluid (e.g., pleural effusions, ascites, pericardial effusions) that requires repeated drainage Active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal conditions that may cause bleeding or perforation by the investigator's discretion Active infection that requires systemic therapy within 1 week before the first dose. Patients receiving prophylactic anti-infective therapy (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) may be eligible after discussion with the sponsor. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with HIV, HBV, or HCV infection may be enrolled after evaluation of eligibility based on FDA's guideline Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections Any other primary malignancy within 3 years before the first dose of study drug, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other curatively treated solid tumors Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and pigmentation) not yet resolved to NCI CTCAE Grade ≤1, baseline, or the level specified in the inclusion/exclusion criteria. Patients with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be eligible after discussion with the sponsor. A history of severe hypersensitivity reactions to the drug substances, inactive ingredients in the drug product, or other monoclonal antibodies Women who are breastfeeding or pregnant as confirmed by pregnancy tests performed within 3 days before the first dose Any illness, medical condition, organ system dysfunction, or social situation, including but not limited to mental illness or substance/alcohol abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results.

Sites / Locations

  • BRCR GlobalRecruiting
  • Karmanos Cancer InstituteRecruiting
  • The University of Texas MD Anderson Cancer CenterRecruiting
  • UT health east Texas HOPE Cancer CenterRecruiting
  • Summit Cancer CenterRecruiting
  • Fujian Cancer HospitalRecruiting
  • Hunan Cancer HospitalRecruiting
  • Jilin Provincial Cancer HospitalRecruiting
  • The First Affiliated Hospital of Zhejiang University School of MedicineRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • Taizhou Hospital of Zhejiang ProvinceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

YL202 Dose escalation

Arm Description

YL202 will be administrated intravenously (IV) per dose level in which the patients are assigned.

Outcomes

Primary Outcome Measures

Evaluate the occurrence of DLTs during the first cycle
Evaluate the AEs as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment

Secondary Outcome Measures

Characterize the PK parameter AUC
Characterize the PK parameter Cmax
Characterize the PK parameter Ctrough
Characterize the PK parameter CL
Characterize the PK parameter Vd
Characterize the PK parameter t1/2
Assess the incidence of anti-YL202 antibodies
Evaluate the objective response rate (ORR)
ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).
Evaluate the disease control rate (DCR)
DCR: defined as the proportion of patients who achieved a best overall response of CR, PR or stable disease (SD).
Evaluate the best tumor response
Best tumor response: defined as the maximum percentage change in the sum of longest dimensions of measurable lesion(s) at any time during the study.

Full Information

First Posted
December 1, 2022
Last Updated
July 3, 2023
Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05653752
Brief Title
A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer
Official Title
A Phase 1, Multicenter, Open-label, First-in-human Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.

4. Oversight

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

5. Study Description

Brief Summary
This is a phase 1, multicenter, open-label, first-in-human study of YL202 conducted in the United States and China. The study will evaluate the safety and tolerability of YL202 in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated NSCLC or hormone receptor (HR)-positive and HER2-negative BC, which have been heavily treated by standard treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
YL202 Dose escalation
Arm Type
Experimental
Arm Description
YL202 will be administrated intravenously (IV) per dose level in which the patients are assigned.
Intervention Type
Drug
Intervention Name(s)
YL202
Intervention Description
YL202 is provided as the lyophilized powder, 200 mg/vial. YL202 will be given intravenously once every 3 weeks (Q3W) as a cycle. The initial dose of YL202 will be infused IV into each patient for 90 ±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL202 will be infused IV into each patient for 60 ±10 minutes.
Primary Outcome Measure Information:
Title
Evaluate the occurrence of DLTs during the first cycle
Time Frame
At the end of Cycle 1 (each cycle is 21 days)
Title
Evaluate the AEs as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment
Time Frame
By the global end of trial date, approximately within 36 months
Secondary Outcome Measure Information:
Title
Characterize the PK parameter AUC
Time Frame
Approximately within 36 months
Title
Characterize the PK parameter Cmax
Time Frame
Approximately within 36 months
Title
Characterize the PK parameter Ctrough
Time Frame
Approximately within 36 months
Title
Characterize the PK parameter CL
Time Frame
Approximately within 36 months
Title
Characterize the PK parameter Vd
Time Frame
Approximately within 36 months
Title
Characterize the PK parameter t1/2
Time Frame
Approximately within 36 months
Title
Assess the incidence of anti-YL202 antibodies
Time Frame
Approximately within 36 months
Title
Evaluate the objective response rate (ORR)
Description
ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).
Time Frame
Approximately within 36 months
Title
Evaluate the disease control rate (DCR)
Description
DCR: defined as the proportion of patients who achieved a best overall response of CR, PR or stable disease (SD).
Time Frame
Approximately within 36 months
Title
Evaluate the best tumor response
Description
Best tumor response: defined as the maximum percentage change in the sum of longest dimensions of measurable lesion(s) at any time during the study.
Time Frame
Approximately within 36 months
Other Pre-specified Outcome Measures:
Title
Evaluate the duration of response (DoR)
Description
DoR: defined as the time interval from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of PD. The DoR will be assessed for patients with a response (CR or PR) only.
Time Frame
Approximately within 36 months
Title
Evaluate the time to response (TTR)
Description
TTR: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of objective response (CR or PR).
Time Frame
Approximately within 36 months
Title
Evaluate the progression-free survival (PFS)
Description
PFS: defined as the time interval from the date of the first dose of study drug to the date of first documentation of PD or death due to any cause, whichever occurs first.
Time Frame
Approximately within 36 months
Title
Evaluate the overall survival (OS)
Description
OS: defined as the time interval from the date of the first dose of study drug to the date of death due to any cause.
Time Frame
Approximately within 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed of the trial before the start of the trial and voluntarily sign their name and date on the informed consent form Aged ≥18 years Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2 Adequate organ and bone marrow function Female patients of childbearing potential must agree to use a highly effective form of contraception and not donate, or retrieve for their own use, ova from the time of screening and throughout the study period, and for at least 6 months after the last dose of study drug. Male patients must agree to use a highly effective form of contraception and not freeze or donate sperm from the time of screening and throughout the study period, and for at least 6 months after the last dose of study drug. Life expectancy of ≥3 months Able and willing to comply with protocol visits and procedures For NSCLC patients: Have a histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC not amenable to curative surgery or radiation Have a documentation of an EGFR-activating mutation (exon 19 deletion or L858R) detected at diagnosis or thereafter Have documentation of disease progression on or after, or are intolerant to prior standard treatment regimens for locally advanced or metastatic disease. For BC patients: Have a histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic HR-positive and HER2-negative BC (per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines) Have documentation of disease progression on or after, or are intolerant to prior standard treatment regimens for locally advanced or metastatic disease. Have at least 1 measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Exclusion Criteria: Intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor, including but not limited to topotecan, irinotecan, and DXd (e.g., severe diarrhea) Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study Inadequate washout period for prior anticancer treatment before the first dose of study drug Undergone major surgery (not including diagnostic surgery) within 4 weeks before the first dose of study drug or expect major surgery during the study Prior allogeneic bone marrow transplantation or solid-organ transplantation Received systemic steroids (>10 mg/day of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks before the first dose of study drug. The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) Systemic steroids at physiological doses as replacement therapy (e.g., physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication) Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study A history of leptomeningeal carcinomatosis Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 2 weeks before the first dose of study drug Uncontrolled or clinically significant cardiovascular disease. A history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that requires steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening Clinically significant concomitant pulmonary disease. Clinically significant corneal disease Have a diagnosis of Gilbert's syndrome Uncontrolled third-space fluid (e.g., pleural effusions, ascites, pericardial effusions) that requires repeated drainage Active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal conditions that may cause bleeding or perforation by the investigator's discretion Active infection that requires systemic therapy within 1 week before the first dose. Patients receiving prophylactic anti-infective therapy (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) may be eligible after discussion with the sponsor. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with HIV, HBV, or HCV infection may be enrolled after evaluation of eligibility based on FDA's guideline Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections Any other primary malignancy within 3 years before the first dose of study drug, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other curatively treated solid tumors Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and pigmentation) not yet resolved to NCI CTCAE Grade ≤1, baseline, or the level specified in the inclusion/exclusion criteria. Patients with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be eligible after discussion with the sponsor. A history of severe hypersensitivity reactions to the drug substances, inactive ingredients in the drug product, or other monoclonal antibodies Women who are breastfeeding or pregnant as confirmed by pregnancy tests performed within 3 days before the first dose Any illness, medical condition, organ system dysfunction, or social situation, including but not limited to mental illness or substance/alcohol abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sasha Stann
Phone
617-240-8494
Email
sasha@medilinkthera.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alan Xu, Ph.D.
Phone
617-871-9455
Email
info@medilinkthera.com
Facility Information:
Facility Name
BRCR Global
City
Plantation
State/Province
Florida
ZIP/Postal Code
33322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
UT health east Texas HOPE Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
Summit Cancer Center
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
Jilin Provincial Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
The First Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Facility Name
Taizhou Hospital of Zhejiang Province
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
317099
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator

12. IPD Sharing Statement

Learn more about this trial

A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer

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