NCT05578092

A Phase 1 Study of MRTX0902 in Solid Tumors With Mutations in the KRAS MAPK Pathway

A Phase 1 Multiple Expansion Cohort Trial of the SOS1 Inhibitor MRTX0902 in Patients With Advanced Solid Tumors Harboring Mutations in the KRAS MAPK Pathway

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Mirati Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, multicenter, study evaluating the safety, tolerability, PK, PD, and anti-tumor activity of MRTX0902 alone and in combination with MRTX849 (adagrasib) in patients with advanced solid tumor malignancy harboring mutations in the KRAS-MAPK pathways.

Detailed description

This first-in-human clinical trial will begin with an exploration of MRTX0902 dose and regimen. Once safety experience and PK data are available for the monotherapy regimen, dose escalation of the combination of MRTX0902 and adagrasib will be initiated, and will include a separate preliminary food effect assessments on MRTX0902 PK in combination with adagrasib. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure collection of sufficient safety and PK information.

Conditions

• Solid Tumor
• Advanced Solid Tumor
• Non Small Cell Lung Cancer
• Colo-rectal Cancer

Interventions

Type	Name	Description
DRUG	MRTX0902	SOS1 inhibitor
DRUG	MRTX849	KRAS G12C inhibitor

Timeline

• Start date: 2022-12-02
• Primary completion: 2026-02-03
• Completion: 2026-02-03
• First posted: 2022-10-13
• Last updated: 2026-02-19

Locations

18 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study