LYT-200 Alone and in Combination With Chemotherapy or Anti-PD-1 in Patients With Metastatic Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cholangiocarcinoma
- Colorectal Cancer
- Metastatic Cancer
- Pancreatic Cancer
- Solid Tumor
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Phase 1/2, two part, open-label study, which will enroll Part 1 and Part 2 sequentially. Part 1 is dose escalation utilizing a continuous reassessment method (CRM) and Part 2 is dose expansion into specific disease indications utilizing a Simon's Two Stage optimal design.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is an open-label, uncontrolled, multicenter Phase 1/2 study with a dose escalation phase (Part 1) and a cohort expansion phase (Part 2) in patients with relapsed/refractory metastatic solid tumors. Part 1: Dose Escalation Phase A dose-finding study will be conducted using a continuous reassessm...
This is an open-label, uncontrolled, multicenter Phase 1/2 study with a dose escalation phase (Part 1) and a cohort expansion phase (Part 2) in patients with relapsed/refractory metastatic solid tumors. Part 1: Dose Escalation Phase A dose-finding study will be conducted using a continuous reassessment method (CRM) to establish dose-limiting toxicities (DLTs) and the recommended Phase 2 dose (RP2D). Part 2: Cohort Expansion Phase The second part of the protocol will adopt a Simon's two-stage optimal design. The Sponsor plans expansion cohorts for specific solid tumors, eg, pancreatic cancer, cholangiocarcinoma and/or potentially other solid tumor types based on results from part 1.
Tracking Information
- NCT #
- NCT04666688
- Collaborators
- Not Provided
- Investigators
- Study Director: Aleksandra Filipovic, MD, Ph.D. PureTech Health
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