NCT03785249

Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 731 (actual)
• Sponsor: Mirati Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.

Detailed description

This study will evaluate the safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 (adagrasib) is an orally-available small molecule inhibitor of KRAS G12C.

Conditions

• Advanced Cancer
• Metastatic Cancer
• Malignant Neoplastic Disease

Interventions

Type	Name	Description
DRUG	MRTX849	MRTX849 will be administered orally once or twice daily in a continuous regimen
DRUG	Pembrolizumab	Pembrolizumab is administered as an intravenous infusion once every 3 weeks
DRUG	Cetuximab	Cetuximab will be administered as an intravenous infusion once per week or once every 2 weeks
DRUG	Afatinib	Afatinib will be administered orally once a day in a continuous regimen

Timeline

• Start date: 2019-01-15
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2018-12-24
• Last updated: 2025-09-30

Locations

222 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study