A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC

NCT ID: NCT06439771

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-23
• Study Completion Date: 2028-07-29

Brief Summary

This study is a multicenter, open-label, phase 2 clinical study to evaluate the efficacy, safety and pharmacokinetics of YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive, HER2-zero-expression or HER2-low-expression

Conditions

Locally Advanced or Metastatic Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Corhort A

YL202 is provided as the lyophilized powder, 200 mg/vial. Triple-negative breast cancer (TNBC) patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.

Group Type: EXPERIMENTAL

YL202 should be intravenously infused

Intervention Type: DRUG

For each patient, YL202 should be intravenously infused over 60±10 min.

Experimental: Corhort B

YL202 is provided as the lyophilized powder, 200 mg/vial. HR-positive breast cancer with HER2-Zero-expression and HER2-Low-expression patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.

Group Type: EXPERIMENTAL

YL202 should be intravenously infused

Intervention Type: DRUG

For each patient, YL202 should be intravenously infused over 60±10 min.

Experimental: Corhort C

YL202 is provided as the lyophilized powder, 200 mg/vial. Breast cancer patients who have previously failed treatments of HER2-ADC or TROP2-ADC (excluding HER2+ patients, ie, HER2 IHC 3+ or IHC 2+/ISH+ patients) will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.

Group Type: EXPERIMENTAL

YL202 should be intravenously infused

Intervention Type: DRUG

For each patient, YL202 should be intravenously infused over 60±10 min.

Interventions

YL202 should be intravenously infused

For each patient, YL202 should be intravenously infused over 60±10 min.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Have been informed of the study before the start of the study and voluntarily sign name and date on the informed consent form.

2. Patients with locally advanced or metastatic disease (according to the UICC and AJCC staging system [Version 8]) who are not candidates for curative surgery or radiotherapy.

3. Patients who are pathologically confirmed advanced/unresectable or metastatic breast cancer with HR-negative and HER2-negative,.

4. Patients who are confirmed HR positive and HER2-Zero-expression and HER2-Low-expression.

5. Breast cancer patients who have previously failed treatments of HER2-ADC or TROP2-ADC.

6. Have at least 1 extracranial measurable lesion as a target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

7. Have Adequate organ and bone marrow function within 7 days prior to the first dose.

8. Female patients of childbearing potential must agree to use highly effective contraception from screening throughout the duration of the study and for at least 6 months after the last dose of study drug.

9. Have a expected survival ≥ 3 months.

10. Have ability and willingness to comply with protocol-specified visits and procedures.

Exclusion Criteria

1. Have prior treatment with an agent targeting HER3.

2. Have prior intolerance to treatment with topoisomerase I inhibitor or an ADC that consists of topoisomerase I inhibitor.

3. Have been enrolled in another clinical study concurrently unless it is an observational clinical study or in the follow-up phase of an interventional study.

4. Have insufficient washout period for prior anticancer therapy prior to first dose of the study drug.

5. Have major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of study drug or anticipation of major surgery during the study.

6. Have prior allogeneic bone marrow transplant or prior solid organ transplant.

7. Have received treatment with systemic steroids.

8. Have received any live vaccine within 4 weeks prior to the first dose of study drug or intend to receive a live vaccine during the study.

9. Leptomeningeal metastases or carcinomatous meningitis, spinal cord compression.

10. Brain metastases with the exceptions.

11. Have uncontrolled or clinically significant cardiovascular and cerebrovascular disease.

12. Have clinically significant concomitant pulmonary diseases.

13. Have a diagnosis of Gilbert's syndrome.

14. Have pleural effusion, abdominal effusion.

15. Have a history of gastrointestinal perforation and or fistula within 6 months prior to the first dose.

16. Have serious infection.

17. Patients with human immunodeficiency virus (HIV) infection.

18. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

19. Have any other primary malignancy within 5 years prior to the first dose of study drug.

20. Have unresolved toxicities from prior anticancer therapy.

21. Have a history of severe hypersensitivity reactions to the drug substance, inactive ingredients in the drug product, or other monoclonal antibodies.

22. Lactating women, or women who are confirmed to be pregnant by pregnancy test within 3 days prior to the first dose.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

MediLink Therapeutics (Suzhou) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

r

Role: CONTACT

Facility Contacts

Coordinator Clinical operation director

Role: primary

RA@medilinkthera.com

Other Identifiers

YL202-CN-202-01

Identifier Type: -

Identifier Source: org_study_id