CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 113 enrolled
Drug / intervention
RMC-4630 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03989115
NCT03989115Phase 2Completed
CompareCT.gov

Ph1b/2 Open-Label,Multicenter Dose-Esc & Dose-Exp Study of Combo RMC4630 & Cobimetinib in Participants w/Relapsed/Refractory Solid Tumors & Ph1b Study of RMC4630 w/Osimertinib in Participants w/EGFR Mutation+,Locally Adv or Meta NSCLC

Revolution Medicines, Inc.·interventional·Posted Jun 18, 2019·Updated Jun 26, 2023

In Brief

A Phase 2 clinical trial evaluating RMC-4630, Cobimetinib, and 1 other intervention for Solid Tumor. Completed, enrolled 113 participants across 24 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor
CountriesSouth Korea, United States
CollaboratorsSanofi

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJun 18, 2019
Enrollment StartJul 2, 2019
Primary CompletionFeb 8, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.0 years ago

Interventions

RMC-4630drug

RMC-4630 for oral administration

Cobimetinibdrug

Cobimetinib for oral administration

Drug: Osimertinibdrug

Osimertinib for oral administration