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Small Molecule Drug

MRTX849 for Cancer

Verified Trial

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

Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation

Unresectable or metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 months

Awards & highlights

Study Summary

This trial will study the effects of MRTX849 on patients with advanced solid tumors that have a KRAS G12C mutation.

Who is the study for?

This trial is for adults with advanced solid tumors that have a specific mutation called KRAS G12C. They should have tried all standard treatments without success or declined them, and their cancer must be inoperable or spread to other parts of the body. People can't join if they have another active cancer, serious gut diseases, major stomach surgery history, trouble swallowing pills, or HER2 positive breast cancer.Check my eligibility

What is being tested?

The study tests MRTX849 (adagrasib) to see how safe it is and how well patients tolerate it. It also looks at what the drug does inside the body and whether it works against cancers with the KRAS G12C mutation. Patients may also receive other drugs like Pembrolizumab, Afatinib, or Cetuximab as part of their treatment.See study design

What are the potential side effects?

Possible side effects from these medications include fatigue, skin reactions, diarrhea and other digestive issues; liver problems; allergic reactions; lung inflammation; changes in blood cell counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has a KRAS G12C mutation.

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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 NSCLC and either there's no standard treatment available or I've declined it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Characterize the safety of MRTX849 in patients having advanced solid tumor malignancies with KRAS G12C mutation

Evaluate clinical activity/efficacy of MRTX849

Evaluate the pharmacokinetics of MRTX849

Secondary outcome measures

Characterize safety and tolerability of MRTX849 in combination with selected therapeutic agents

Establish maximum tolerated dose

Evaluate the pharmacokinetics of MRTX849 administered with food

+1 more

Trial Design

9Treatment groups

Experimental Treatment

Group I: Pilot Phase 1b Combination with PembrolizumabExperimental Treatment2 Interventions

Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with pembrolizumab in patients with NSCLC

Group II: Pilot Phase 1b Combination with Cetuximab in PDACExperimental Treatment2 Interventions

Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with pancreatic adenocarcinoma (PDAC)

Group III: Pilot Phase 1b Combination with Cetuximab in NSCLCExperimental Treatment2 Interventions

Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with NSCLC

Group IV: Pilot Phase 1b Combination with CetuximabExperimental Treatment2 Interventions

Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with cetuximab in patients with CRC

Group V: Pilot Phase 1b Combination with AfatinibExperimental Treatment2 Interventions

Phase 1 evaluation of the safety, tolerability, PK and clinical activity of MRTX849 in combination with afatinib in patients with NSCLC

Group VI: Phase 2 Combination with CetuximabExperimental Treatment2 Interventions

Phase 2 evaluation of the clinical activity of MRTX849 in combination with cetuximab in patients with CRC

Group VII: Phase 2Experimental Treatment1 Intervention

Separate cohorts of patients stratified by histological diagnosis, prior treatment history or co-mutation status (e.g., STK11) for evaluation of clinical activity of MRTX849

Group VIII: Phase 1b ExpansionExperimental Treatment1 Intervention

Expansion cohort to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 to recommend Phase 2 regimens

Group IX: Phase 1 Dose ExplorationExperimental Treatment1 Intervention

Dose escalation of MRTX849 to determine maximum tolerated dose

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Afatinib

2016

Completed Phase 4

~2340

MRTX849

2021

Completed Phase 1

~10

Cetuximab

2011

Completed Phase 3

~2480

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mirati Therapeutics Inc.Lead Sponsor

70 Previous Clinical Trials

7,383 Total Patients Enrolled

Hirak Der-TorossianStudy DirectorMirati Therapeutics

Richard ChaoStudy DirectorMirati Therapeutics

Media Library

MRTX849 (Small Molecule Drug) Clinical Trial Eligibility Overview. Trial Name: NCT03785249 — Phase 1 & 2

Cancer Research Study Groups: Pilot Phase 1b Combination with Cetuximab in NSCLC, Phase 1 Dose Exploration, Phase 1b Expansion, Phase 2, Pilot Phase 1b Combination with Afatinib, Pilot Phase 1b Combination with Pembrolizumab, Phase 2 Combination with Cetuximab, Pilot Phase 1b Combination with Cetuximab in PDAC, Pilot Phase 1b Combination with Cetuximab

Cancer Clinical Trial 2023: MRTX849 Highlights & Side Effects. Trial Name: NCT03785249 — Phase 1 & 2

MRTX849 (Small Molecule Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03785249 — Phase 1 & 2

Frequently Asked Questions

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

What are the goals that researchers hope to accomplish with this clinical trial?

"The purpose of this 20-month study is to monitor MRTX849's clinical activity/efficacy. Additionally, researchers will aim to understand the safety and tolerability of MRTX849 when used in combination with other drugs. They will also take blood plasma concentration measurements to assess MRTX849's pharmacokinetics under different conditions."

Answered by AI

Are volunteers being accepted for this experiment at this moment?

"According to clinicaltrials.gov, this study is still looking for volunteers and was last updated on February 4th, 2022. It was originally posted on January 15th, 2019."

Answered by AI

How many patients will be given the chance to participate in this clinical trial?

"This study, which is being conducted by Mirati Therapeutics Inc., needs a total of 740 patients that meet the inclusion criteria. The trial will take place at different sites including USOR - Compass Oncology - Vancouver in Vancouver, Washington and Charleston Oncology P.A. in Charleston, South carolina."

Answered by AI

What are the conditions that MRTX849 is used to treat?

"MRTX849 is most frequently used to target malignant neoplasms, however it can also be an effective tool in treating microsatellite instability high, high risk of recurrence, and intolerance to irinotecan."

Answered by AI

Does MRTX849 have a long and well-documented history of use?

"First studied in 2005 at the Mamie McFaddin Ward Cancer Center, MRTX849 has had 703 completed trials as of now. There are presently 1155 active trials, a majority of which are being performed in Vancouver, Washington."

Answered by AI

What is the global reach of this clinical trial?

"There are 79 sites running this clinical trial, a few of which include Vancouver, Charleston and Newport News. It may be helpful to choose the location nearest you in order to limit travel if you decide to participate."

Answered by AI

Have similar tests been conducted previously with other patients?

"First researched in 2005, MRTX849 was initially trialed by Bristol-Myers Squibb with 154 participants. The success of the first study led to the drug's Phase 2 approval. As of now, there are 1,155 ongoing trials for MRTX849 in 3,258 cities and 65 different countries."

Answered by AI