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A First-in-Human Study of YL217 in Patients With Advanced Solid Tumors
About
Brief Summary
A Phase 1 First-in-Human study of YL217 in Patients with Advanced Solid Tumors
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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 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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Study Stats
Protocol No.
25-1053
Category
Colorectal Cancer
Esophageal Cancer
Other Cancer
Pancreatic Cancer
Stomach Cancer
Principal Investigator
Contact
- Bindu Cherian
Location
- UCLA Santa Monica
- UCLA Westwood