NCT03674567

Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination with Pembrolizumab

Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: RAPT Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab. The study will be conducted in 2 parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
DRUG	FLX475	tablet
DRUG	pembrolizumab (KEYTRUDA®)	IV infusion

Timeline

• Start date: 2018-09-25
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2018-09-17
• Last updated: 2025-01-24

Locations

35 sites across 6 countries: United States, Australia, Hong Kong, South Korea, Taiwan, Thailand

Regulatory

• FDA-regulated drug study