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MAPK Pathway Inhibitor

MRTX0902 + MRTX849 for Solid Tumors

Phase 1 & 2

Recruiting

Research Sponsored by Mirati Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of a tumor lesion amenable to mandatory biopsy for pharmacodynamic evaluation at baseline and on-study

Unresectable or metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial tests the safety and effectiveness of two cancer drugs to treat advanced tumors with KRAS or MAPK mutations.

Who is the study for?

This trial is for adults with advanced solid tumors that have specific mutations in the KRAS-MAPK pathway, who can't be cured by other treatments or choose not to undergo them. Participants must have a tumor that can be biopsied, measurable disease, good organ function, and an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory).Check my eligibility

What is being tested?

The study tests MRTX0902 alone and combined with MRTX849 (adagrasib) on patients with certain genetic changes in their tumors. It's an early-stage trial to check how safe these drugs are, how the body processes them, and if they work against cancer.See study design

What are the potential side effects?

Possible side effects include typical reactions from cancer medications such as nausea, fatigue, diarrhea; however specific side effects will depend on patient response to MRTX0902 and adagrasib which target mutations within cancer cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor can be biopsied for study purposes.

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My cancer cannot be removed by surgery or has spread to other parts of my body.

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I have no curative treatment options left or available to me.

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My cancer was confirmed through testing and has specific genetic changes.

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I am fully active or have some restrictions but can still care for myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1: Number of Patients who Experience Dose-Limiting Toxicity

Phase 2: Duration of response (DOR)

Phase 2: Objective response rate (ORR)

+3 more

Secondary outcome measures

Apparent total plasma clearance when dosed orally

Apparent volume of distribution when dosed orally

Area under the plasma concentration versus time curve

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase 2Experimental Treatment2 Interventions

MRTX0902 and adagrasib combination RP2D administered to separate cohorts of patients with selected solid tumor malignancies with KRAS G12C mutation to include the following: NSCLC, CRC, Other Solid Tumors

Group II: Phase 1/1B MonotherapyExperimental Treatment1 Intervention

Dose Escalation/Evaluation

Group III: Phase 1/1B Combination TherapyExperimental Treatment2 Interventions

Dose Escalation/Evaluation and Food Effect Assessment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MRTX849

2021

Completed Phase 1

~10

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mirati Therapeutics Inc.Lead Sponsor

70 Previous Clinical Trials

7,977 Total Patients Enrolled

Curtis Chin, MD, PhDStudy DirectorMirati Therapeutics Inc.

Media Library

MRTX0902 (MAPK Pathway Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05578092 — Phase 1 & 2

Non-Small Cell Lung Cancer Research Study Groups: Phase 2, Phase 1/1B Monotherapy, Phase 1/1B Combination Therapy

Non-Small Cell Lung Cancer Clinical Trial 2023: MRTX0902 Highlights & Side Effects. Trial Name: NCT05578092 — Phase 1 & 2

MRTX0902 (MAPK Pathway Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05578092 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for this research endeavor?

"As of today, this medical research is still looking for participants. It was initially posted on the 4th of November 2022 and has been updated most recently on the 8th of November 2022."

Answered by AI

What are the major aims of this clinical experiment?

"The leading sponsor of this study, Mirati Therapeutics Inc., has identified Phase 2 Progression Free Survival as the primary outcome metric to be evaluated over a three week period. Secondary objectives include Time To Maximum Plasma Concentration, Area Under The Plasma Concentration Versus Time Curve and Apparent Total Plasma Clearance when Administered Orally for MRTX0902 and Adagrasib respectively."

Answered by AI

Approximately how many participants has the clinical trial recruited?

"Absolutely. According to clinicaltrials.gov, this medical trial is actively seeking participants and was initially posted on November 4th 2022. The study's most recent update occurred on November 8th of the same year and requires 225 patients from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1/2 Study of MRTX0902 in Solid Tumors With Mutations in the KRAS MAPK Pathway

2022. "A Phase 1/2 Study of MRTX0902 in Solid Tumors With Mutations in the KRAS MAPK Pathway". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05578092.

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