A Study of YL242 in Subjects With Advanced Solid Tumors

Not Applicable

Recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: YL242; Drug: YL242; Pembrolizumab; Drug: YL242; 5-FU; LV; Drug: YL242; Pembrolizumab; 5-FU

• Registration Number: NCT07197827
• Lead Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-22
• Study First Submitted: 2025-09-26
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study First Posted: 2025-09-29
• Last Update Posted: 2025-09-29
• Primary Completion: 2028-09
• Study Completion: 2028-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 424

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 1 and Part 2: Mono Dose Escalation & Expansion	YL242	Participants receive YL242 administered via intravenous (IV) solution per protocol defined dose level and frequency.
Part 3 and 4: Combination Dose Escalation & Expansion	YL242; Pembrolizumab	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.
Part 5: Combination Dose Optimization and Expansion	YL242; 5-FU; LV	Participants receive YL242, 5-FU and LV, administered via intravenous (IV) solution.
Part 6: Combination Dose Optimization and Expansion	YL242; Pembrolizumab; 5-FU	Participants receive YL242, pembrolizumab and 5-FU, administered via intravenous (IV) solution at protocol defined frequency.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Area Under the Serum Concentration Time Curve (AUC) of YL242	Approximately within 36 months
Maximum Plasma Concentration (Cmax) of YL242	Approximately within 36 months
Time to Maximum Plasma Concentration (Tmax) of YL242	Approximately within 36 months
Incidence of anti-YL242 antibody	Approximately within 36 months
Terminal Elimination Half-life (t1/2) of Serum YL242	Approximately within 36 months
Disease Control Rate (DCR)	Approximately within 36 months	Disease control rate (DCR) was calculated as the proportion of participants demonstrating complete response (CR), partial response (PR), or stable disease.

Trial Locations

Locations (15)

US-201; 🇺🇸 New Haven, Connecticut, United States

US-202; 🇺🇸 Sarasota, Florida, United States

US-204; 🇺🇸 Boston, Massachusetts, United States

US-206; 🇺🇸 Grand Rapids, Michigan, United States

US-205; 🇺🇸 Nashville, Tennessee, United States

US-203; 🇺🇸 Houston, Texas, United States

US-207; 🇺🇸 San Antonio, Texas, United States

AUS-101; 🇦🇺 Liverpool, New South Wales, Australia

AUS-102; 🇦🇺 Darlinghurst, Victoria, Australia

AUS-104; 🇦🇺 Fitzroy, Victoria, Australia

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