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A Study of YL242 in Subjects With Advanced Solid Tumors

RecruitingPhase 1/2

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.

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. · Participants: 424 · Started: Sep 22, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07197827

Locations in the U.S.

ConnecticutUS-201, New Haven (Not yet recruiting)
FloridaUS-202, Sarasota
MassachusettsUS-204, Boston (Not yet recruiting)
MichiganUS-206, Grand Rapids
TennesseeUS-205, Nashville
TexasUS-203, Houston (Not yet recruiting)
US-207, San Antonio (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.