Phase 1/1B Monotherapy for Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Colorectal Cancer+3 MoreMRTX0902 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a Phase 1/2, 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.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Solid Tumors
  • Advanced Solid Tumors
  • Colorectal Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 6 Secondary · Reporting Duration: 2 years

2 years
Phase 2: Duration of response (DOR)
Phase 2: Objective response rate (ORR)
Phase 2: Overall survival (OS)
Phase 2: Progression free survival (PFS)
21 Days
Phase 1: Number of Patients who Experience Dose-Limiting Toxicity
Up to 2 years
Phase1/1B: Number of patients who experience a treatment-related adverse event
Up to 4 days
Apparent total plasma clearance when dosed orally
Apparent volume of distribution when dosed orally
Area under the plasma concentration versus time curve
Maximum observed plasma concentration
Terminal elimination half-life
Time to achieve maximal plasma concentration

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Phase 1/1B Monotherapy
1 of 3
Phase 1/1B Combination Therapy
1 of 3
Phase 2
1 of 3

Experimental Treatment

225 Total Participants · 3 Treatment Groups

Primary Treatment: Phase 1/1B Monotherapy · No Placebo Group · Phase 1 & 2

Phase 1/1B Monotherapy
Drug
Experimental Group · 1 Intervention: MRTX0902 · Intervention Types: Drug
Phase 1/1B Combination TherapyExperimental Group · 2 Interventions: MRTX0902, MRTX849 · Intervention Types: Drug, Drug
Phase 2Experimental Group · 2 Interventions: MRTX0902, MRTX849 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRTX849
2021
Completed Phase 1
~10

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Mirati Therapeutics Inc.Lead Sponsor
59 Previous Clinical Trials
6,977 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients with KRAS G12C mutation are eligible for this study.
Treatment is not available or patient refuses treatment.
You have evaluable disease.
You have measurable disease.\n
You have a tumor lesion amenable to mandatory biopsy at baseline and on-study.
You have no known organ dysfunction.