RecruitingPhase 1Phase 2NCT07169994

A Study of YL202 in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors

A Multi-center, Open-Label, Phase Ib/II Study of YL202 in Combination With Anti-tumor Therapy to Evaluate the Safety, Tolerability, and Efficacy in Patients With Advanced Solid Tumors

Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Enrollment

414 participants

Start Date

Sep 2, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Advanced Solid Tumors

Summary

This is a multicenter, open-label, phase Ib/II study of YL202 in combination with other anti-tumor therapies to Evaluate the Safety, Tolerability, and Efficacy in Patients with Advanced Solid Tumors

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing YL202, an antibody-drug conjugate (a targeted therapy that delivers a cancer-killing drug directly to tumor cells) that targets a protein called HER3. It is being tested in combination with other anti-cancer drugs in people with advanced solid tumors. **You may be eligible if...** - You are between 18 and 75 years old - You have an advanced solid tumor (specific cancer types eligible may vary by combination arm) - You are in reasonably good health (ECOG 0 or 1) - You have at least one measurable tumor outside the brain - You have received prior standard treatment for your cancer, or have not yet been treated in the metastatic setting - Archived tumor tissue is available from a prior biopsy **You may NOT be eligible if...** - You have previously received a drug targeting HER3 - You have had prior CAR T-cell therapy - You have active or unstable brain metastases - You have significant heart, liver, or lung problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGYL202 for injection; Toripalimab injection

Part 1: YL202 and Toripalimab will be administered intravenously. Part 3: participants will receive escalating doses of YL202 and fixed dose of Toripalimab until YL202 doses for optimization are determined. Dose expansion stage: participants will receive a dose of YL202 not exceeding the maximum dose level achieved during the dose-escalation stage and fixed dose of Toripalimab

DRUGYL202 for injection; Furmonertinib Mesilate Tablets

Part 2: YL202 will be administered intravenously，Furmonertinib Mesilate Tablets will be administered orally. Dose escalation stage: participants will receive escalating doses of YL202 and fixed dose of Furmonertinib Mesilate until YL202 doses for optimization are determined. Part 4: participants will receive a dose of YL202 not exceeding the maximum dose level achieved during the dose-escalation stage and fixed dose of Furmonertinib Mesilate.

Locations(20)

Anhui Provincial Hospital(The First Affiliated Hospital of Ustc)

Hefei, Anhui, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Meizhou People's Hospital（Huangtang Hospital）Meizhou Academy of Medical Sciences

Meizhou, Guangdong, China

Ghang xi Medical University Cancer Hospital

Nanning, Guangxi, China

Affiliated Hospital Of Hebei University

Baoding, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Anyang Cancer Hospital

Anyang, Henan, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

The First People's Hospital of Changde City

Changde, Hunan, China

Jiangsu Province Hospital（The First Affiliated Hospital With Nanjing Medical University, Jiangsu Women And Children Health Hospital)

Nanjing, Jiangsu, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Affiliated Zhongshan Hospital Dalian University

Dalian, Liaoning, China

Liaoning cancer hospital &institute

Shenyang, Liaoning, China

Affiliated Zhongshan Hospital Dalian University

Jinan, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

Sichuan Academy of Medical Sciences&Sichuan Provincial People's Hospital

Sichuan, Sichuan, China

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT07169994

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