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

Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
Study ID
NCT07208773
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • YL201 — DRUG
    YL201 will be administered as IV infusion
  • Ivonescimab — DRUG
    Ivonescimab will be administered as IV infusion.

Study Details

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

Key Dates

Start date
Oct 29, 2025
Status verified
Nov 2025
Primary completion
Jan 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
260 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1： Safety run-in
    Multiple dose levels of YL201 will be explored in combination with Ivonescimab administered intravenously (IV) at a fixed dose.Participants receive YL201 and Ivonescimab (AK112) on Day 1 of each 3-week cycle, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent as specified in the protocol.
  • Experimental: Phase 2： Dose expansion
    YL201 will be administered at the selected RDE in combination with Ivonescimab administered IV at a fixed dose. Participants receive YL201+ Ivonescimab (AK112) on Day 1 of each 3-week cycle, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent as specified in the protocol.

Primary Outcome Measure

Incidence and severity of adverse events (AEs) [ Time Frame: Approximately within 36 months ]

Central Contacts

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