YL242 treatment for people with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter Phase 1/2 trial tests YL242 as monotherapy and in combination with pembrolizumab and chemotherapy across multiple cohorts of adults with advanced solid tumors. Phase 1 will use dose-escalation to define safety, tolerability, and recommended doses, followed by expansion cohorts in Phase 2 that enroll tumor-specific groups such as non-squamous NSCLC, colorectal, and gastric cancers. Eligible participants generally must be adults with ECOG 0–1 and adequate organ function, with most cohorts requiring prior systemic therapy while some cohorts enroll treatment‑naïve patients. Primary endpoints focus on safety and tolerability, with secondary endpoints capturing preliminary anti-tumor activity and pharmacokinetics.

Why it matters

Who can join: the full rules

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

Where it's running

• Us-202
  Sarasota, Florida, United States Recruiting
• Us-206
  Grand Rapids, Michigan, United States Recruiting
• Us-205
  Nashville, Tennessee, United States Recruiting
• Aus-102
  Darlinghurst, Victoria, Australia Recruiting
• Cn-303
  Harbin, Heilongjiang, China Recruiting
• Cn-301
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Medilink Study Team
• Email: clinicaltrials@medilinkthera.com
• Phone: +86 0512-62858368

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.