A Study of YL242 in Subjects With Advanced Solid Tumors

NCT07197827 · tracked via the Priya Life Science China tracker

Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Phase

Phase 1/2

Started

2025-09-22

Last updated

2025-12-24

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

YL242YL242; PembrolizumabYL242; 5-FU; LVYL242; Pembrolizumab; 5-FU

YL242: The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes.

YL242; Pembrolizumab: The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes. Pembrolizumab will be administered subsequent to YL242.

YL242; 5-FU; LV: The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes. LV and 5-FU will be sequentially administered following YL242.

YL242; Pembrolizumab; 5-FU: The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. YL242 will be administered via Intravenous (IV) Infusion. Pembrolizumab and 5-FU will be administered in sequence after YL242.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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.

Trial sites (15)

Facility	City	Region	Status
US-201	New Haven	Connecticut	Not Yet Recruiting
US-202	Sarasota	Florida	Recruiting
US-204	Boston	Massachusetts	Not Yet Recruiting
US-206	Grand Rapids	Michigan	Recruiting
US-205	Nashville	Tennessee	Recruiting
US-203	Houston	Texas	Not Yet Recruiting
US-207	San Antonio	Texas	Not Yet Recruiting
AUS-101	Liverpool	New South Wales	Not Yet Recruiting
AUS-102	Darlinghurst	Victoria	Recruiting
AUS-104	Fitzroy	Victoria	Not Yet Recruiting
AUS-103	Heidelberg	Victoria	Not Yet Recruiting
AUS-105	Nedlands	Western Australia	Not Yet Recruiting
CN-303	Harbin	Heilongjiang	Recruiting
CN-301	Shanghai	Shanghai Municipality	Recruiting
CN-302	Hangzhou	Zhejiang	Recruiting

More MediLink Therapeutics (Suzhou) Co., Ltd. trials in China

A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma. Recruiting

A Study to Compare the Efficacy and Safety of YL201 With Standard Chemotherapy in Patients With Metastatic Pancreatic Cancer After Failure of Gemcitabine-Based Systemic Chemotherapy Starting soon

A Clinical Study of YL205 in Patients With Advanced Solid Tumors Recruiting

A First-in-Human Study of YL217 in Patients With Advanced Solid Tumors Recruiting

YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer Recruiting

Other trials for the same condition

A Study of MHB036C for Advanced Solid Tumor Active, not recruiting

A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors Active, not recruiting

Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors Recruiting

HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors Recruiting

A Clinical Study of [177Lu]Lu-XT117 Injection in Patients With Advanced Solid Tumors Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07197827 on ClinicalTrials.gov ↗ ← All trials in China