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A Study of YL242 in Subjects With Advanced Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

A Study of YL242 in Subjects With Advanced Solid Tumors

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.

NCT07197827•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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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

Key Dates

Start Date

September 22, 2025

Primary Completion Date

September 1, 2028

Completion Date

November 1, 2028

Last Updated

December 24, 2025

Enrollment

424

ESTIMATED participants

Conditions

Advanced Solid Tumor

Interventions

YL242

DRUG

YL242; Pembrolizumab

DRUG

YL242; 5-FU; LV

DRUG

YL242; Pembrolizumab; 5-FU

DRUG

Contacts

Medilink Study Team

CONTACT

+86 0512-62858368 clinicaltrials@medilinkthera.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of YL242 in Subjects With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

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