drugset / Trial / NCT02675946
CGX1321 in Subjects With Advanced Solid Tumors and CGX1321 With Pembrolizumab or Encorafenib + Cetuximab in Subjects With Advanced GI Tumors (Keynote 596)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, open-label study conducted in two phases: Phase 1 consisting of a CGX1321 Single Agent Dose Escalation Phase in solid tumors, CGX1321 Single Agent Dose Expansion Phase in GI tumors and Roll-over Cohort of CGX1321 and pembrolizumab in subjects who have progressed on single agent CGX1321 and Phase 1b consisting of CGX1321 in combination with pembrolizumab in colorectal tumors and CGX1321 in combination with encorafenib + cetuximab in BRAFV600E mutated colorectal tumors. Both phases are to evaluate safety, pharmacokinetics, and clinical activity.
Timeline
- Start
- 2016-02
- Primary completion
- 2023-03
- Completion
- 2023-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CGX1321 | Unknown | — | Oral |
| Background | Cetuximab | Monoclonal antibody | — | Intravenous |
| Background | Encorafenib | Small molecule | — | Oral |
| Background | Pembrolizumab | Monoclonal antibody | — | Intravenous |