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NCT07208773PHASE1, PHASE2RECRUITING

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. + Akesobio

No open prediction endpoints

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Key Facts

Study type
INTERVENTIONAL
Conditions
Advanced Solid Tumors, Non Small Cell Lung Cancer, Small Cell Lung Cancer
Interventions
YL201, Ivonescimab
Enrollment
260 participants
Primary completion
Jan 2027
Study completion
Dec 2027
First posted
Oct 2025
Last updated
Nov 2025

Primary Endpoints (CT.gov)

Incidence and severity of adverse events (AEs)

Time frame: Approximately within 36 months

Maximum tolerate dose(MTD)

Time frame: Approximately within 36 months

Recommended Dose for Expansion

Time frame: Approximately within 36 months

Objective Response Rate (ORR)

Time frame: Approximately within 36 months

Secondary Endpoints

Area Under the Concentration-time Curve (AUC)

maximum concentration (Cmax)

minimum concentration at trough (Ctrough)

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 pa

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov