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

Launched by MEDILINK THERAPEUTICS (SUZHOU) CO., LTD. · Mar 4, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called YL217 for patients with advanced solid tumors, which are types of cancer that form in solid organs like the stomach, pancreas, or intestines. This is a Phase 1 study, meaning it’s one of the first times this treatment is being tested in people. The trial is not yet recruiting participants, but it aims to find out if YL217 is safe and effective for adults aged 18 and older who have specific types of advanced cancers that have not responded to previous treatments.

To participate in this study, patients must be willing to follow the study rules and procedures. They should have a confirmed diagnosis of an advanced solid tumor and have measurable cancer that can be tracked during the study. Additionally, patients need to have good overall health and organ function. There are some conditions and previous treatments that could disqualify someone from joining, such as recent surgery or prior treatment with certain cancer drugs. If eligible, participants will receive the study treatment and will be closely monitored by healthcare professionals throughout the trial to ensure their safety and to see how well the treatment works.

Gender

ALL

Eligibility criteria

• Inclusion 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:
• • 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 Criteria:
• • 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.