Study of CTX-471 as a Monotherapy or in Combination With Pembrolizumab in Patients Post PD-1/PD-L1 Inhibitors in Metastatic or Locally Advanced Malignancies
Summary
This is a Phase 1, open-label, first-in-human study of CTX-471 administered as a monotherapy or in combination with pembrolizumab in patients with metastatic or locally advanced malignancies that have progressed while receiving an approved PD-1 or PD-L1 inhibitor. The study will be conducted in 2 treatment arms (Monotherapy Arm 1 and Combination Arm 2). Each arm will have two parts: Part 1 Dose Escalation and Part 2 Dose Expansion. In each arm (monotherapy and combination therapy), data from Part 1 (dose escalation) and Part 2 (dose expansion) were combined by dose level for reporting.
Timeline
- Start
- 2019-05-17
- Primary completion
- 2025-05-21
- Completion
- 2025-05-21
Outcome
Outcome not reported
Stopped (Enrollment): “The combination therapy arm of the study with pembrolizumab did not yield an efficacy signal, so enrollment into the combination therapy arm was terminated. The monotherapy arm of the study was fully enrolled and completed.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CTX-471 | Unknown | 0.3 mg/kg | Intravenous |
| Subject | CTX-471 | Unknown | 0.6 mg/kg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 400 mg | Intravenous |