A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1/2
Started

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Record History

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  1. Trial sites expanded: 22 → 38 locations
    • Secondary endpoints: details revised at 1 of 9 entries
    • Eligibility criteria expanded, about 5 words
  2. Trial sites expanded: 4 → 22 locationsv3
  3. Recruitment opened
    • Trial sites expanded: 1 → 4 locations
    • Start date changed from estimate of Mar 2026 to Mar 31, 2026
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a phase Ib/II, multicenter, open-label study of YL201 combined with atezolizumab. The study will include 2 parts. Part 1 of the study is a dose escalation in participants with previously untreated ES-SCLC to determine the safety and tolerability of YL201 in combination with fixed dose of atezolizumab. The planned dose levels of YL201 are 1.2 mg/kg, 1.6 mg/kg and 2.0 mg/kg. Part 2 consists of a dose optimization stage followed by a dose expansion stage. During the dose optimization stage, participants will be randomized 1:1:1 to receive either YL201 at 1.2 mg/kg,1.6 mg/kg or 2.0 mg/kg Q3W in combination with fixed dose of atezolizumab. The decision to initiate the dose expansion stage in Part 2 and choose one or two of the YL201 dose level(s) will be based on the review of safety, PK, and efficacy from the dose optimization stage. Treatment will continue until disease progression, unacceptable toxicity, or withdraw of consent.
Trial Details
NCT Number NCT07407933
Lead Sponsor MediLink Therapeutics (Suzhou) Co., Ltd.
Collaborators: Hoffmann-La Roche, Genentech, Inc.
Conditions
(from sponsor)		 Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma
Related terms Lung Diseases, Small Cell Lung Carcinoma, Thoracic Neoplasms
Enrollment 118 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov