Spots Global Cancer Trial Database for Combination Therapy of RMC-4630 and LY3214996 in Metastatic KRAS Mutant Cancers

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Trial Identification

Brief Title: Combination Therapy of RMC-4630 and LY3214996 in Metastatic KRAS Mutant Cancers

Official Title: Phase I/Ib Study With the Combination of RMC-4630 (SHP2 Inhibitor) and LY3214996 (ERK Inhibitor) in Metastatic KRAS Mutant CRC, PDAC and NSCLC

Study ID: NCT04916236

Conditions

Pancreatic Cancer

Colorectal Cancer

Non-small Cell Lung Cancer

KRAS Mutation-Related Tumors

Interventions

RMC-4630

LY3214996

Study Description

Brief Summary: This is a Phase I/Ib study in which the safety of the combination therapy of RMC-4630 and LY3214996 in the treatment of KRAS mutant cancers will be studied.

Detailed Description: This is a phase I / Ib study in which the safety of the combination therapy of RMC-4630 and LY3214996 in the treatment of KRAS mutant cancers colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma will be studied. The phase I dose-escalation study is designed to identify the recommended phase 2 dose (RP2D) of the combination regimen of RMC-4630 (SHP2-inhibitor) plus LY3214996 (ERK-inhibitor) in patients with KRASm CRC, NSCLC or PDAC. The phase Ib expansion cohort is designed to further characterize the safety of the selected dose from the first stage of the study and to explore the clinical activity of RMC-4630 in combination with LY3214996 in patients with metastatic KRASm PDAC.