NCT06412198

A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if the drug combination of adagrasib, cetuximab, and cemiplimab can help to control metastatic CRC with KRAS G12C mutations.

Detailed description

Primary Objective • To determine the objective response rate of the adagrasib, cetuximab, and cemiplimab combination for treatment of advanced KRAS G12C MT CRC that has progressed on at least one line of prior systemic chemotherapy. Secondary Objectives * To estimate duration of response (DOR), progression free survival (PFS), and overall survival (OS) for the combination of adagrasib, cetuximab, and cemiplimab in participants with advanced KRAS G12C MT CRC that has progressed on at least one line of prior systemic chemotherapy. * To estimate the safety and tolerability of the combination of adagrasib, cetuximab, and cemiplimab in participants with advanced KRAS G12C MT CRC that has progressed on at least one line of prior systemic chemotherapy. Exploratory Objectives * To assess predictive biomarkers of response and resistance to the combination of adagrasib, cetuximab, plus cemiplimab. * To assess mechanisms of tumor cell adaptation upon treatment with the combination of adagrasib, cetuximab, plus cemiplimab. * To determine mechanisms of acquired resistance to the combination of adagrasib, cetuximab, plus cemiplimab. * To assess the effect of the combination of adagrasib, cetuximab plus cemiplimab on the immune tumor microenvironment. * To generate cell lines and participant derived xenograft (PDX) models from tumor samples.

Conditions

• Metastatic Colorectal Cancer
• KRAS G12C Mutations

Interventions

Type	Name	Description
DRUG	Cetuximab	Given by IV
DRUG	Cemiplimab	Given by IV
DRUG	Adagrasib	Given by PO

Timeline

• Start date: 2024-08-28
• Primary completion: 2029-03-01
• Completion: 2029-03-01
• First posted: 2024-05-14
• Last updated: 2026-03-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study