A Study of YL242 in Subjects With Advanced Solid Tumors

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
Study ID
NCT07197827
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • YL242 — DRUG
    The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes.
  • YL242; Pembrolizumab — DRUG
    The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes. Pembrolizumab will be administered subsequent to YL242.
  • YL242; 5-FU; LV — DRUG
    The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes. LV and 5-FU will be sequentially administered following YL242.
  • YL242; Pembrolizumab; 5-FU — DRUG
    The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. YL242 will be administered via Intravenous (IV) Infusion. Pembrolizumab and 5-FU will be administered in sequence after YL242.

Study Details

This is a multicenter, open-label study to evaluate the safety and tolerability of YL242 monotherapy and combination in participants with advanced solid malignant tumors.

Key Dates

Start date
Sep 22, 2025
Status verified
Dec 2025
Primary completion
Sep 30, 2028
Completion
Nov 30, 2028

Study Design

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

Arms

  • Experimental: Part 1 and Part 2: Mono Dose Escalation & Expansion
    Participants receive YL242 administered via intravenous (IV) solution per protocol defined dose level and frequency.
  • Experimental: Part 3 and 4: Combination Dose Escalation & Expansion
    Participants receive YL242 at protocol defined dose level, in combination with Pembrolizumab (200 mg), administered via intravenous (IV) solution at protocol defined dose level and frequency.
  • Experimental: Part 5: Combination Dose Optimization and Expansion
    Participants receive YL242, 5-FU and LV, administered via intravenous (IV) solution.
  • Experimental: Part 6: Combination Dose Optimization and Expansion
    Participants receive YL242, pembrolizumab and 5-FU, administered via intravenous (IV) solution at protocol defined frequency.

Primary Outcome Measure

Objective Response Rate (ORR) in Participants With Advanced Solid Malignant Tumors (Part 2, and 4-6) [ Time Frame: Approximately within 36 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
US-201New HavenConnecticut06519
study coordinator
US-202SarasotaFlorida34232
study coordinator
US-204BostonMassachusetts02215
study coordinator
US-206Grand RapidsMichigan49546
study coordinator
US-205NashvilleTennessee37203
study coordinator
US-203HoustonTexas77030
study coordinator
US-207San AntonioTexas78229
study coordinator

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