CLN-617 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
Trial Parameters
Brief Summary
CLN-617-001 is a Phase 1, open-label, dose escalation, dose optimization and dose expansion study of CLN-617 alone and in combination with Pembrolizumab in patients with advanced solid tumors
Eligibility Criteria
Inclusion Criteria: 1. Aged ≥ 18 years. 2. Patient should have previously received or had a contraindication to standard therapy that confers an overall survival benefit. 3. Part 1 Dose Escalation Cohorts: Histologically or cytologically confirmed advanced incurable or metastatic non-neurological solid tumor with accessible injectable lesions. 4. Part 2 Dose Optimization: Histologically or cytologically confirmed select advanced incurable or metastatic cancer types with accessible injectable lesions. 5. Part 3 Dose Expansions: 1. Cohort 1: Histologically or cytologically confirmed metastatic or locally advanced, unresectable melanoma with accessible injectable lesions. 2. Cohort 2: Histologically or cytologically confirmed metastatic or locally advanced, unresectable HNSCC with accessible injectable lesions. 6. Patients must have 2 or more measurable lesions for Part 1, or one or more measurable lesions for Part 2 and Part 3 that meet RECIST v1.1. Also, patients must have tumors able t