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
Endpoints are classified and published by ProgramSignal analysts.
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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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