Status:
RECRUITING
A Study of YL242 in Subjects With Advanced Solid Tumors
Lead Sponsor:
MediLink Therapeutics (Suzhou) Co., Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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.
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:
- 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
- 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
Key Trial Info
Start Date :
September 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
424 Patients enrolled
Trial Details
Trial ID
NCT07197827
Start Date
September 22 2025
End Date
November 1 2028
Last Update
December 24 2025
Active Locations (15)
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1
US-201
New Haven, Connecticut, United States, 06519
2
US-202
Sarasota, Florida, United States, 34232
3
US-204
Boston, Massachusetts, United States, 02215
4
US-206
Grand Rapids, Michigan, United States, 49546