Status:
RECRUITING
A Study of YL201 and Ivonescimab (AK112) in Advanced Solid Tumors
Lead Sponsor:
MediLink Therapeutics (Suzhou) Co., Ltd.
Collaborating Sponsors:
Akesobio
Conditions:
Advanced Solid Tumors
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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
- Age ≥ 18 years old.
- Inclusion criteria for the study population： Phase 1: Advanced Solid tumors. Phase 2: Extensive-stage SCLC, Non-AGA NSCLC, EGFR mutation NSCLC.
- ECOG PS score is 0 or 1.
- Within 7 days before the first dose, the functions of body organs and bone marrow meet the requirements.
Exclusion
- Suitable for local curative treatment.
- Have received previous treatment with drugs targeting B7-H3 (including antibodies, ADCs, CAR-T, and other drugs).
- Have received previous treatment with topoisomerase I inhibitors or ADCs containing topoisomerase I inhibitors.
- Have experienced grade ≥ 3 irAEs during previous treatment with anti-programmed death receptor (ligand) \[anti-PD-(L)1\] or other immune checkpoint inhibitors.
- History of bleeding tendency or coagulation disorders and/or clinically significant bleeding symptoms or risks within 4 weeks before randomization.
- Imaging studies during the screening period show that the patient has the Imaging-confirmed tumor invasion of major blood vessels.
- Active autoimmune disease requiring systemic treatment.
- Brain metastases or spinal cord compression.
- Patients with uncontrolled or clinically significant cardiovascular diseases.
- Clinically significant concurrent pulmonary diseases.
- Known to have active pulmonary tuberculosis. Other protocol-defined inclusion/ exclusion criteria may apply
Key Trial Info
Start Date :
October 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT07208773
Start Date
October 29 2025
End Date
December 1 2027
Last Update
November 17 2025
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060