drugset / Trial / NCT03989115

Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC

NCT03989115

Phase 1/2 Completed 113 enrolled Revolution Medicines, Inc. Sanofi · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of RMC-4630 and cobimetinib in adult participants with relapsed/refractory solid tumors with specific genomic aberrations and to identify the recommended Phase 2 dose (RP2D); and to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of RMC-4630 and osimertinib in adult participants with EGFR mutation-positive locally advanced or metastatic NSCLC.

Timeline

Start
2019-07-02
Primary completion
2022-02-08
Completion
2022-02-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Cobimetinib Small molecule Oral
Subject Osimertinib Small molecule Oral
Subject Vociprotafib Small molecule Oral

Indications