Recruiting

YL242 Monotherapy and Combinations for Advanced Solid Tumors

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What is being tested

YL242

+ YL242; Pembrolizumab

+ YL242; 5-FU; LV

Drug
Who is being recruted

Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorMediLink Therapeutics (Suzhou) Co., Ltd.
Study ContactMedilink Study Team
Last updated: December 25, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: September 22, 2025

Actual date on which the first participant was enrolled.

This clinical trial is designed to investigate a new treatment option for patients with advanced solid tumors, which are a type of cancer that has spread and is not easily treated. The study focuses on a new drug named YL242 and aims to understand how safe and tolerable it is when used alone or in combination with other treatments. Patients with these advanced tumors often have limited treatment options, so this study is important because it may lead to new ways to manage their condition effectively. Participants in this study will receive YL242, either on its own or alongside other therapies, and their health will be closely monitored. The treatment is administered in a controlled setting, and researchers will evaluate how the drug behaves in the body and its effects on the tumors. The main focus is to see if the treatment is safe and how well it is tolerated by patients. Through regular health assessments, the study aims to gather comprehensive information on the potential benefits and any possible side effects of YL242, contributing to the development of better cancer treatments.

Official TitleA 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
Principal SponsorMediLink Therapeutics (Suzhou) Co., Ltd.
Study ContactMedilink Study Team
Last updated: December 25, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

424 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neoplasms

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants receive YL242 administered via intravenous (IV) solution per protocol defined dose level and frequency.

Group II

Experimental
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.

Group III

Experimental
Participants receive YL242, 5-FU and LV, administered via intravenous (IV) solution.

Group IV

Experimental
Participants receive YL242, pembrolizumab and 5-FU, administered via intravenous (IV) solution at protocol defined frequency.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 15 locations

Recruiting

US-202

Sarasota, United StatesSee the location
Recruiting

US-206

Grand Rapids, United States
Recruiting

US-205

Nashville, United States
Recruiting

AUS-102

Darlinghurst, Australia
Recruiting
15 Study Centers