NCT06130254

Phase Ib Trial of the KRAS G12C Inhibitor Adagrasib (MRTX849) in Combination With the PARP Inhibitor Olaparib in Patients With KRAS G12C Mutated Advanced Solid Tumors, With a Focus on Gynecological, Breast, Pancreatic and KEAP1 Mutated Non-small Cell Lung Cancers

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

Summary

Evaluate safety and tolerability, while establishing the recommended dose of the investigational drug combination of adagrasib and olaparib that can be given to participants with advanced solid tumor(s) with a KRAS G12C and/or KEAP1 mutation.

Detailed description

Primary Objectives * To evaluate the safety and tolerability of adagrasib in combination with olaparib in participants with KRAS G12C mutant advanced solid tumors. * To establish the maximum tolerated dose and/or recommended phase 2 dose (MTD/RP2D) of the combination in participants with KRAS G12C mutant advanced solid tumors. Secondary Objectives * To assess the preliminary antitumor activity of the combination of adagrasib in combination with olaparib using objective response rate (ORR) = RECISTv1.1 complete response plus partial response (CR+PR). Exploratory Objectives * To assess predictive biomarkers of response and resistance to the combination of adagrasib with olaparib. * To evaluate the pharmacodynamic profile of the combination of adagrasib and olaparib in participants with KRAS G12C mutant advanced solid tumors. * To assess potential mechanisms of response and resistance by comparing serially collected circulating tumor DNA (ctDNA) samples and biopsies in responders and non-responders.

Conditions

• Advanced Solid Tumor
• Non-small Cell Lung Cancers

Interventions

Type	Name	Description
DRUG	Adagrasib	Given by PO BID
DRUG	Olaparib	Given by PO BID

Timeline

• Start date: 2024-01-30
• Primary completion: 2024-06-14
• Completion: 2026-03-30
• First posted: 2023-11-14
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study