RECRUITING

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

Description

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

Study Overview

Study Details

Study overview

A Phase 1 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

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

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Santa Monica

UCLA Hematology/Oncology - Santa Monica, Santa Monica, California, United States, 90404

New Haven

Yale Cancer Center, New Haven, Connecticut, United States, 06519

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Detroit

Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

Cleveland

Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, United States, 44195

Houston

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

San Antonio

UT Health San Antonio - Mays Cancer Center, San Antonio, Texas, United States, 78229

Madison

University of Wisconsin Health - UW Carbone Cancer Center, Madison, Wisconsin, United States, 53792

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

MediLink Therapeutics (Suzhou) Co., Ltd.,

Study Record Dates

2027-07