Clinical Trials Search
Clinical Trial 20577
Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT03989115
Phase: Phase I/II
Prinicipal Investigator: Eric Haura
Study Title
A Phase 1b/2, Open-Label, Multicenter Dose-Escalation and Dose-Expansion Study of the Combination of RMC-4630 and Cobimetinib in Adult Participants with Relapsed/Refractory Solid Tumors with Specific Genomic Aberrations
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.
Objective
Primary Objectives: To characterize the safety and tolerability of the combination of RMC-4630 and cobimetinib in participants with relapsed/refractory solid tumors To define the MTD and RP2D and schedules for the combination of RMC-4630 and cobimetinib in participants with relapsed/refractory solid tumors Secondary Objectives: To characterize the plasma PK of RMC-4630 and cobimetinib when administered concurrently To estimate the anti-tumor effects of RMC-4630 in combination with cobimetinib at the RP2D in participants with relapsed/refractory solid tumors harboring specific genotypic aberrations in the RAS-MAPK pathway Tertiary/Exploratory Objectives: To estimate the anti-tumor effects of RMC-4630 in combination with cobimetinib in all participants To characterize the PD effects of RMC-4630 and cobimetinib in combination in blood and/or tumor tissue To identify PD markers of drug activity of RMC-4630 and cobimetinib in combination To evaluate preclinically predefined predictive genomic biomarker models and explore further predictive and prognostic biomarker strategies. Assessment of longitudinal effects of RMC-4630 and cobimetinib on the clonal dynamics of the tumor
Therapies
Medications
AZD9291 (Osimertinib); Cobimetinib (); Osimertinib (); RMC-4630 ()
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