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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
- YL242 (drug)
- YL242; Pembrolizumab (drug)
- YL242; 5-FU; LV (drug)
- YL242; Pembrolizumab; 5-FU (drug)
Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. · Participants: 424 · Started: Sep 22, 2025
Contact the study team
- Medilink Study Team · Phone: +86 0512-62858368
Official record on ClinicalTrials.gov — NCT07197827
Locations in the U.S.
| Connecticut | US-201, New Haven (Not yet recruiting) |
| Florida | US-202, Sarasota |
| Massachusetts | US-204, Boston (Not yet recruiting) |
| Michigan | US-206, Grand Rapids |
| Tennessee | US-205, Nashville |
| Texas | US-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.