NCT04916236

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer
• Colorectal Cancer
• Non-small Cell Lung Cancer
• KRAS Mutation-Related Tumors

Interventions

Type	Name	Description
DRUG	RMC-4630	* SHP2-inhibitor * Powder in capsule * Administered on day 1 and day 2 of every week
DRUG	LY3214996	* ERK inhibitor * Powder in capsule * Administered every day

Timeline

• Start date: 2022-03-31
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2021-06-07
• Last updated: 2025-01-24

Locations

1 site across 1 country: Netherlands