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Clinical Trials in China / NCT06859762
Recruiting Phase 1

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

NCT06859762 · tracked via the Priya Life Science China tracker
Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
Phase
Phase 1
Started
2025-07-02
Last updated
2026-09-18

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

YL217Bevacizumab5-FU with leucovorin

YL217: Patients will receive specific dose of YL217 administered via intravenous(IV)infusion.

Bevacizumab: Participants will receive bevacizumab administered via intravenous(IV) infusion,at 5mg/kg,Q2W.

5-FU with leucovorin: Participants will receive 5 fluorouracil 2400mg/m2 and leucovorin 400mg/m2, administered via intravenous (IV) infusion, Q2W

Study summary

A Phase 1 First-in-Human study of YL217 in Patients with Advanced Solid Tumors

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Informed of the study before the start of the study and voluntarily sign their name and date in the ICF * Able and willing to comply with protocol visits and procedures * Age≥ 18 years * ECOG PS of 0 or 1 * Pathologically confirmed diagnosis of an advanced solid tumor. For CRC cohorts: : Histologically or cytologically documented locally advanced unresectable or metastatic colorectal carcinoma that is not eligible for curative surgery and/or definitive chemoradiotherapy * Adequate organ and bone marrow function. * Have at least 1 extracranial measurable tumor lesion. * Adequate archival formalin-fixed paraffin embedded (FFPE) tissue from prior biopsy. Exclusion Criteria: * Prior treatment with an agent targeting CDH17 * Prior discontinuation of a topoisomerase I inhibitor due to treatment-related toxicities. * Have received an ADC consisting of a topoisomerase I inhibitor. * Concurrent enrollment in another clinical study, unless it is an observational clinical study. * Inadequate washout period for prior anticancer treatment before the first dose of study drug * Undergone major surgery within 4 weeks before the first dose of study drug or expect major surgery during the study, minor procedures (e.g., core needle biopsy, superficial biopsy) within 7 days before the first dose of study drug. * Received long term systemic steroids or other immunosuppressive therapy within 2 weeks before the first dose of study drug. * Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study. * Diagnosis or evidence of spinal cord compression or leptomeningeal carcinomatosis. * Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases. * A history of non-infectious interstitial lung disease (ILD)/pneumonitis that requires steroids, current active ILD/pneumonitis. * Have clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses. * Uncontrolled third-space fluid that requires repeated drainage. * Digestive system disease that may cause bleeding, perforation, jaundice, fistula, GI obstruction within 6 months prior to the first dose of study drug administration or have active inflammatory bowel disease. * An active tuberculosis based on medical history. * Known human immunodeficiency virus (HIV) infection. * Active hepatitis C infection.

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
Mayo Clinic Arizona Phoenix Arizona Recruiting
UCLA Hematology/Oncology - Santa Monica Santa Monica California Recruiting
Yale Cancer Center New Haven Connecticut Recruiting
The University of Kansas Cancer Center (KUCC) Kansas City Kansas Recruiting
Karmanos Cancer Institute Detroit Michigan Recruiting
Columbia University Irving Medical Center New York New York Recruiting
Duke University Medical Center (DUMC) Durham North Carolina Recruiting
University of Cincinnati Medical Center Cincinnati Ohio Recruiting
Cleveland Clinic Taussig Cancer Institute Cleveland Ohio Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting
UT Health San Antonio - Mays Cancer Center San Antonio Texas Recruiting
University of Wisconsin Health - UW Carbone Cancer Center Madison Wisconsin Recruiting
Peking Union Medical College Hospital Beijing Bejing Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong Not Yet Recruiting
Harbin Medical University Cancer Hospital Harbin Heilongjiang Recruiting
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi Not Yet Recruiting
The First Affiliated Hospital of China Medical University Shenyang Liaoning Not Yet Recruiting
Cancer Hospital of Shandong First Medical University Jinan Shandong Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai Municipality Recruiting
Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin Municipality Recruiting
Zhejiang Cancer Hospital Hangzhou Zhejiang Recruiting

On this site

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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 NCT06859762 on ClinicalTrials.gov ↗ ← All trials in China