🔎 Trials Near Me

Home › NCT06859762

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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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

What is being tested

Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. · Participants: 630 · Started: Jul 2, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06859762

Locations in the U.S.

ArizonaMayo Clinic Arizona, Phoenix
CaliforniaUCLA Hematology/Oncology - Santa Monica, Santa Monica
ConnecticutYale Cancer Center, New Haven
KansasThe University of Kansas Cancer Center (KUCC), Kansas City
MichiganKarmanos Cancer Institute, Detroit
New YorkColumbia University Irving Medical Center, New York
North CarolinaDuke University Medical Center (DUMC), Durham
OhioUniversity of Cincinnati Medical Center, Cincinnati
Cleveland Clinic Taussig Cancer Institute, Cleveland
TexasThe University of Texas MD Anderson Cancer Center, Houston
UT Health San Antonio - Mays Cancer Center, San Antonio
WisconsinUniversity of Wisconsin Health - UW Carbone Cancer Center, Madison

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.