A Study of YL202 in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors

Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
Study ID
NCT07169994
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • YL202 for injection; Toripalimab injection — DRUG
    Part 1: YL202 and Toripalimab will be administered intravenously. Part 3: participants will receive escalating doses of YL202 and fixed dose of Toripalimab until YL202 doses for optimization are determined. Dose expansion stage: participants will receive a dose of YL202 not exceeding the maximum dose level achieved during the dose-escalation stage and fixed dose of Toripalimab
  • YL202 for injection; Furmonertinib Mesilate Tablets — DRUG
    Part 2: YL202 will be administered intravenously，Furmonertinib Mesilate Tablets will be administered orally. Dose escalation stage: participants will receive escalating doses of YL202 and fixed dose of Furmonertinib Mesilate until YL202 doses for optimization are determined. Part 4: participants will receive a dose of YL202 not exceeding the maximum dose level achieved during the dose-escalation stage and fixed dose of Furmonertinib Mesilate.

Study Details

This is a multicenter, open-label, phase Ib/II study of YL202 in combination with other anti-tumor therapies to Evaluate the Safety, Tolerability, and Efficacy in Patients with Advanced Solid Tumors

Key Dates

Start date
Sep 2, 2025
Status verified
Sep 2025
Primary completion
Sep 1, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
414 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: YL202 in combination with Toripalimab
    Part 1 (dose escalation stage and backfill stage) \& Part 3 (dose expansion stage): YL202 for injection in combination with Toripalimab injection
  • Experimental: YL202 in combination with Furmonertinib Mesilate
    Part 2 (dose escalation stage and backfill stage) \& Part 4 (dose expansion stage): YL202 for injection in combination with Furmonertinib Mesilate Tablets

Primary Outcome Measure

Nature and frequency of dose-limiting toxicity (DLT) [ Time Frame: 21 days after the first dose was administered to each subject. ]

Central Contacts

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