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RECRUITING
NCT07197827
PHASE1/PHASE2

A Study of YL242 in Subjects With Advanced Solid Tumors

Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 1/2, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL242 Monotherapy and Combinations in Advanced Solid Tumors.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

424

Start Date

2025-09-22

Completion Date

2028-11

Last Updated

2025-12-24

Healthy Volunteers

No

Interventions

DRUG

YL242

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.

DRUG

YL242; Pembrolizumab

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.

DRUG

YL242; 5-FU; LV

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.

DRUG

YL242; Pembrolizumab; 5-FU

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.

Locations (15)

US-201

New Haven, Connecticut, United States

US-202

Sarasota, Florida, United States

US-204

Boston, Massachusetts, United States

US-206

Grand Rapids, Michigan, United States

US-205

Nashville, Tennessee, United States

US-203

Houston, Texas, United States

US-207

San Antonio, Texas, United States

AUS-101

Liverpool, New South Wales, Australia

AUS-102

Darlinghurst, Victoria, Australia

AUS-104

Fitzroy, Victoria, Australia

AUS-103

Heidelberg, Victoria, Australia

AUS-105

Nedlands, Western Australia, Australia

CN-303

Harbin, Heilongjiang, China

CN-301

Shanghai, Shanghai Municipality, China

CN-302

Hangzhou, Zhejiang, China