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Recruiting Phase 1, Phase 2 NCT07208773

A Study of YL201 and Ivonescimab (AK112) in Advanced Solid Tumors

Trial Parameters

Condition Advanced Solid Tumors
Sponsor MediLink Therapeutics (Suzhou) Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 260
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-10-29
Completion 2027-01
Interventions
YL201Ivonescimab

Brief Summary

This study was designed to evaluate the efficacy and safety of YL201 in combination with Ivonescimab (AK112) in subjects with solid tumor.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥ 18 years old. 2. Inclusion criteria for the study population: Phase 1: Advanced Solid tumors. Phase 2: Extensive-stage SCLC, Non-AGA NSCLC, EGFR mutation NSCLC. 3. ECOG PS score is 0 or 1. 4. Within 7 days before the first dose, the functions of body organs and bone marrow meet the requirements. Exclusion Criteria: 1. Suitable for local curative treatment. 2. Have received previous treatment with drugs targeting B7-H3 (including antibodies, ADCs, CAR-T, and other drugs). 3. Have received previous treatment with topoisomerase I inhibitors or ADCs containing topoisomerase I inhibitors. 4. Have experienced grade ≥ 3 irAEs during previous treatment with anti-programmed death receptor (ligand) \[anti-PD-(L)1\] or other immune checkpoint inhibitors. 5. History of bleeding tendency or coagulation disorders and/or clinically significant bleeding symptoms or risks within 4 weeks before randomization. 6. Imaging studies during the screening period show that the patie

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