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

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor

In brief

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

Key facts

Study ID

NCT06859762

Run by

MediLink Therapeutics (Suzhou) Co., Ltd.

People needed

220

Starts

2025-07-02

Expected to finish

2027-07-01

Last updated by the study team

2026-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Tumor types as below:
• For Part 1 and Part 2: Pathologically confirmed diagnosis of an advanced solid tumor.
• For Part 3 (Histologically or cytologically confirmed diagnosis+ locally advanced unresectable or metastatic disease)
• 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.

You may not qualify if…

• 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.
• 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, gastrointestinal obstruction.
• An active tuberculosis based on medical history.
• Known human immunodeficiency virus (HIV) infection.
• Active hepatitis C infection.

Where it is running

• Mayo Clinic Arizona — Phoenix, Arizona, United States (enrolling)
• UCLA Hematology/Oncology - Santa Monica — Santa Monica, California, United States (enrolling)
• Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• The University of Kansas Cancer Center (KUCC) — Kansas City, Kansas, United States (enrolling)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• UT Health San Antonio - Mays Cancer Center — San Antonio, Texas, United States (enrolling)
• Peking Union Medical College Hospital — Beijing, Bejing, China (enrolling)
• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• Columbia University Irving Medical Center — New York, New York, United States (enrolling)
• Duke University Medical Center (DUMC) — Durham, North Carolina, United States (enrolling)
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States (enrolling)
• Cleveland Clinic Taussig Cancer Institute — Cleveland, Ohio, United States (enrolling)
• University of Maryland Medical Center-Greenebaum Cancer Ctr - Medical Oncology — Baltimore, Maryland, United States
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
• Cancer Hospital of Shandong First Medical University — Jinan, Shandong, China
• University of Wisconsin Health - UW Carbone Cancer Center — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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