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

Advanced Solid Tumor

Over 18 Years
+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 2025

See protocol details

Summary

Principal SponsorMediLink Therapeutics (Suzhou) Co., Ltd.
Study ContactMedilink Study Team
Last updated: September 29, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 22, 2025Actual 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. 
Principal SponsorMediLink Therapeutics (Suzhou) Co., Ltd.
Study ContactMedilink Study Team
Last updated: September 29, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive treatments one after another in a pre-planned sequence. The next treatment may depend on how the participant responds to the previous one.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Advanced Solid Tumor
Criteria
8 inclusion criteria required to participate
Aged ≥18 years
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
Adequate organ and bone marrow function
Tumor type

Show More Criteria

5 exclusion criteria prevent from participating
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

Show More Criteria

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

Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response \[CR\] or partial response \[PR\] per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

AEs will be collected systematically from signing of the informed consent form (ICF) through 42 days after last dose.
Secondary Objectives

Disease control rate (DCR) was calculated as the proportion of participants demonstrating complete response (CR), partial response (PR), or stable disease.

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
CN-301Shanghai, ChinaSee the location
Recruiting soon
US-201New Haven, United States
Recruiting soon
US-202Sarasota, United States
Recruiting soon
US-204Boston, United States
Recruiting
15 Study Centers