RecruitingPhase 1NCT06859762
A 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
Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
Enrollment
220 participants
Start Date
Jul 2, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A Phase 1 First-in-Human study of YL217 in Patients with Advanced Solid Tumors
Eligibility
Min Age: 18 Years
Inclusion Criteria10
- 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 Criteria17
- 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.
- 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.
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Interventions
DRUGYL217
Patients will be treated with YL217 intravenous(IV)infusion.
DRUGYL217
Patients will be treated with YL217 intravenous(IV)infusion.
DRUGYL217
Patients will be treated with YL217 intravenous(IV)infusion.
Locations(19)
View Full Details on ClinicalTrials.gov
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NCT06859762
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