RecruitingPhase 1Phase 2NCT07208773

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

A Multi-center, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of YL201 in Combination With Ivonescimab in Patients With Advanced Solid Tumors


Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Enrollment

260 participants

Start Date

Oct 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests two new cancer drugs — YL201 and Ivonescimab (AK112) — in people with advanced solid tumors, including small cell lung cancer and certain types of non-small cell lung cancer. **You may be eligible if...** - You are 18 or older - You have advanced solid tumors (Phase 1), or specifically extensive-stage small cell lung cancer, EGFR-mutant NSCLC, or non-AGA NSCLC (Phase 2) - You are in good overall health (ECOG score 0 or 1) - Your organ function and blood counts are within required ranges **You may NOT be eligible if...** - Your cancer could be treated with a local curative approach - You have previously received drugs that target B7-H3 - You have previously received topoisomerase I inhibitor drugs or antibody-drug conjugates containing them - You had severe immune-related side effects (grade 3 or higher) from prior immunotherapy - You have certain active infections or other serious health conditions 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

DRUGYL201

YL201 will be administered as IV infusion

DRUGIvonescimab

Ivonescimab will be administered as IV infusion.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

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NCT07208773


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