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NCT07197827PHASE1, PHASE2Recruiting

A Study of YL242 in Subjects With Advanced Solid Tumors

MediLink Therapeutics (Suzhou) Co., Ltd.

Start Date

9/22/2025

Completion Date

11/1/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Aged ≥18 years. * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 * Adequate organ and bone marrow function * Tumor type: Part 1-3: Advanced/unresectable or metastatic solid malignant tumor; Have received at least one prior line of systemic anti-tumor therapy Part 4: locally advanced or metastatic non-sq NSCLC without AGA and HCC; Have not received any systemic anti-tumor therapy; Part 5: mCRC, have received at least one (5a) or one (5b) prior line of systemic anti-tumor therapy Part 6: advanced or metastatic HER2-negative G/GEJ; have received at least one (6a) or one (6b) prior line of systemic anti-tumor therapy Exclusion Criteria: * Be intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor * Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases * Clinically significant concomitant pulmonary disease * A history of leptomeningeal carcinomatosis or carcinomatous meningitis * Any illness, medical condition, organ system dysfunction, or social situation, including but not limited to mental illness or substance/alcohol abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results

Interventions

DRUG

YL242

DRUG

YL242; Pembrolizumab

DRUG

YL242; 5-FU; LV

DRUG

YL242; Pembrolizumab; 5-FU

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Conditions

Advanced Solid Tumor

Locations

US-201

New Haven, Connecticut 06519

United States

US-202

Sarasota, Florida 34232

United States

US-204

Boston, Massachusetts 02215

United States

US-206

Grand Rapids, Michigan 49546

United States

US-205

Nashville, Tennessee 37203

United States

US-203

Houston, Texas 77030

United States

US-207

San Antonio, Texas 78229

United States

AUS-101

Liverpool, New South Wales 2170

Australia

AUS-102

Darlinghurst, Victoria 2010

Australia

AUS-104

Fitzroy, Victoria 3065

Australia

AUS-103

Heidelberg, Victoria 3084

Australia

AUS-105

Nedlands, Western Australia 6009

Australia

CN-303

Harbin, Heilongjiang 150081

China

CN-301

Shanghai, Shanghai Municipality 200030

China

CN-302

Hangzhou, Zhejiang 310022

China