RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-07-02

Study Completion:2027-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06859762

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Informed of the study before the start of the study and voluntarily sign their name and date in the informed consent form (ICF) * Able and willing to comply with protocol visits and procedures * Aged ≥ 18 years * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 * Tumor types as below: * 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.	* Prior treatment with an agent targeting CDH17 * Prior discontinuation of a topoisomerase I inhibitor due to treatment-related toxicities. * Have received a topoisomerase I inhibitor within protocol defined time before the first dose of study drug. * 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.

Inclusion Criteria

Exclusion Criteria

* Informed of the study before the start of the study and voluntarily sign their name and date in the informed consent form (ICF)
* Able and willing to comply with protocol visits and procedures
* Aged ≥ 18 years
* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
* Tumor types as below:
* 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.

* Prior treatment with an agent targeting CDH17
* Prior discontinuation of a topoisomerase I inhibitor due to treatment-related toxicities.
* Have received a topoisomerase I inhibitor within protocol defined time before the first dose of study drug.
* 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.

Contacts and Locations

Study Contact

Qiaoyun Wang, MD

CONTACT

+86 0512-62858368

info@medilinkthera.com

Study Locations (Sites)

UCLA Hematology/Oncology - Santa Monica

Santa Monica, California, 90404

United States

Yale Cancer Center

New Haven, Connecticut, 06519

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

Columbia University Irving Medical Center

New York, New York, 10032

United States

Cleveland Clinic Taussig Cancer Institute

Cleveland, Ohio, 44195

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

UT Health San Antonio - Mays Cancer Center

San Antonio, Texas, 78229

United States

University of Wisconsin Health - UW Carbone Cancer Center

Madison, Wisconsin, 53792

United States

Collaborators and Investigators

Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-02

Study Completion Date2027-07

Study Record Updates

Study Start Date2025-07-02

Study Completion Date2027-07

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumor