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A Study of YL242 for Advanced Solid Tumors

This study is testing a drug called YL242, both on its own and in combination with other treatments like Pembrolizumab, 5-FU, and LV. It's for people with advanced solid tumors who have already received at least one other treatment. The main goals are to see how many people respond to the treatment (Objective Response Rate) and to track any side effects (adverse events). You would be eligible if you are 18 or older, have a good performance status (ECOG PS of 0 or 1), and have adequate organ function. The study aims to enroll 424 participants, but its current status is unclear.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It is designed to evaluate the safety and tolerability of YL242 alone and with other drugs in about 424 participants.
What's involved
The initial dose of YL242 will be given through an IV for about 90 minutes. If there are no infusion reactions, later doses will also be given this way.
Compensation
Not stated in the trial record.
Follow-up
Side effects will be tracked from the start of treatment up to 42 days after the last dose, for approximately 36 months.

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NCT07197827

A Study of YL242 in Subjects With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
MediLink Therapeutics (Suzhou) Co., Ltd.
~424 participants
Updated 2025-12-24 on ClinicalTrials.gov
What's tested:YL242YL242; PembrolizumabYL242; 5-FU; LVYL242; Pembrolizumab; 5-FU

At a glance

Recruiting sites
7 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR) in Participants With Advanced Solid Malignant Tumors (Part 2, and 4-6)
Measured over Approximately within 36 months
+1 more outcome measured

Conditions

Advanced Solid Tumor

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Where it's being run

15 sites across 12 states
Victoria3
Texas2
Connecticut1
Florida1
Massachusetts1
Michigan1
Tennessee1
New South Wales1

Who to contact

Medilink Study Team
[email protected]
+86 0512-62858368
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Aged ≥18 years.
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
Adequate organ and bone marrow function
Tumor type:

Exclusion

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

What this trial measures

  • Objective Response Rate (ORR) in Participants With Advanced Solid Malignant Tumors (Part 2, and 4-6)Approximately within 36 months

    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.

  • Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)Baseline up to 42 days post last patients last dose, approximately within 36 months

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