Study of NKTR 255 in Combination With Cetuximab in Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colorectal Cancer (CRC)
- Head and Neck Squamous Cell Carcinoma (HNSCC)
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Phase 1: Dose escalation cohorts will be sequential Phase 2: Cohorts A and B will be in parallelMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This study is a Phase 1b/2, open-label, multicenter dose escalation and dose expansion study in patients with R/R HNSCC or CRC. NKTR-255 is a cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects. After an initial cetuximab loa...
This study is a Phase 1b/2, open-label, multicenter dose escalation and dose expansion study in patients with R/R HNSCC or CRC. NKTR-255 is a cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects. After an initial cetuximab loading dose during the study run-in period (Day -7), patients will receive IV NKTR-255 every 21 days in combination with cetuximab weekly. In the dose escalation phase, beginning with Dose Level 1, successive cohorts will receive ascending doses of NKTR-255 until the MTD and/or RP2D is determined. Patients who achieve optimal response (partial response or complete response), will be given the option to continue treatment with NKTR-255 as single agent for maintenance. Enrollment into Phase 2 will commence once the RP2D is established in Phase 1b. The RP2D of NKTR-255 will be evaluated in expansion Cohorts A and B. Cohort A will combine NKTR-255 and cetuximab in patients with R/R HNSCC and Cohort B will combine NKTR-255 and cetuximab in patients with R/R CRC.
Tracking Information
- NCT #
- NCT04616196
- Collaborators
- Not Provided
- Investigators
- Study Director: Study Director Nektar Therapeutics