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A Study of YL202 in Selected Patients With Advanced Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Study of YL202 in Selected Patients With Advanced Solid Tumors

A Multicenter, Open-Label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Selected Patients With Advanced Solid Tumors

NCT06107686•MediLink Therapeutics (Suzhou) Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in the following selected patients with advanced solid tumors.

Detailed Description

This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in the advanced NSCLC/BC/HNSCC/colorectal cancer/HER2-positive gastric cancer/cervical cancer/ovarian cancer and etc.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects who are aware of relevant trial information before the start of the trial, and voluntarily sign and date on the informed consent form (ICF).
•2. Subjects aged from 18-75 (inclusive) years.
•3. Histologically or cytologically confirmed at diagnosis of NSCLC/BC/HNSCC/other locally advanced or metastatic solid tumors including but not limited to colorectal cancer, HER2-positive gastric cancer, cervical cancer, ovarian cancer, etc..
•4. At least one extracranial measurable lesion according to RECIST 1.1.
•5. Archived or fresh tumor tissue samples can be provided.
•6. With Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
•7. The function of organs and bone marrow meets the requirements within 7 days before the first dose.
•8. Female subjects of childbearing potential must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product. Male subjects must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product.
•9. With expected survival ≥ 3 months.
•10. Be capable of and willing to comply with the visits and procedures stipulated in the study protocol.

Exclusion Criteria

•1. With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates \[ADCs\]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs).
•2. Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.
•3. Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study.
•4. The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product.
•5. Patients who have received major surgery (excluding diagnostic surgery) within 4 weeks before the first dose of the investigational product or those who are expected to receive major surgery during the study.
•6. Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.
•7. Prior treatment with systemic steroids (prednisone \> 10 mg/day or equivalent) or other immunosuppressive treatment within 2 weeks before the first dose of the investigational product.
•8. Patients who have received any live vaccine within 4 weeks before the first dose of the investigational product or those who plan to receive live vaccine during the study period.
•9. With meningeal metastasis or cancerous meningitis.
•10. With brain metastasis or spinal cord compression.
+13 more criteria

Locations (82)

Anhui Tumour Hospital

Hefei, Anhui, China

The first affiliated hospital of Anhui Medical University

Hefei, Anhui, China

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Cancer hospital

Beijing, Beijing Municipality, China

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Chinese First Affiliated Hospital of Army Medical University of the People's Liberation Army

Chongqing, Chongqing Municipality, China

Chongqing University Affiliated Tumor Hospital

Chongqing, Chongqing Municipality, China

The first affiliated hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Key Dates

Start Date

December 15, 2023

Primary Completion Date

November 1, 2026

Completion Date

November 1, 2028

Last Updated

November 26, 2025

Enrollment

200

ESTIMATED participants

Conditions

NSCLCBreast CancerHNSCCLocally Advanced or Metastatic Solid Tumors

Interventions

YL202 should be intravenously infused

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of YL202 in Selected Patients With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

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