drugset / Trial / NCT03881488

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

NCT03881488

Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2019-05-17
Primary completion
2025-05-21
Completion
2025-05-21

Drugs

EvaluationDrugModalityDoseRoute
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