RecruitingPhase 1NCT06859762

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

A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL217 in Patients With Advanced Solid Tumors


Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Enrollment

220 participants

Start Date

Jul 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria10

  • 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.

Exclusion Criteria17

  • 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.

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Interventions

DRUGYL217

Patients will be treated with YL217 intravenous(IV)infusion.

DRUGYL217

Patients will be treated with YL217 intravenous(IV)infusion.

DRUGYL217

Patients will be treated with YL217 intravenous(IV)infusion.


Locations(19)

Mayo Clinic Arizona

Phoenix, Arizona, United States

UCLA Hematology/Oncology - Santa Monica

Santa Monica, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

The University of Kansas Cancer Center (KUCC)

Kansas City, Kansas, United States

University of Maryland Medical Center-Greenebaum Cancer Ctr - Medical Oncology

Baltimore, Maryland, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Columbia University Irving Medical Center

New York, New York, United States

Duke University Medical Center (DUMC)

Durham, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Cleveland Clinic Taussig Cancer Institute

Cleveland, Ohio, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

UT Health San Antonio - Mays Cancer Center

San Antonio, Texas, United States

University of Wisconsin Health - UW Carbone Cancer Center

Madison, Wisconsin, United States

Peking Union Medical College Hospital

Beijing, Bejing, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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