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Recruiting Phase 1 NCT06859762

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

Trial Parameters

Condition Advanced Solid Tumor
Sponsor MediLink Therapeutics (Suzhou) Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 220
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-07-02
Completion 2027-07
Interventions
YL217YL217YL217

Brief Summary

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

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 * 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 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

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