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KRAS G12D Inhibitor

MRTX1133 for Solid Cancers

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
Age ≥ 18 years
Histologically confirmed diagnosis of a solid tumor malignancy harboring KRAS G12D mutation in tumor tissue or ctDNA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial studies a new drug to see how safe and effective it is on patients with certain types of cancer.

Who is the study for?
This trial is for adults with advanced solid tumors that have a specific mutation called KRAS G12D. Participants must have tried standard treatments without success, be in fairly good health and physical condition (ECOG status of 0 or 1), and their cancer should not be removable by surgery. They can't join if they've had certain gastrointestinal issues, brain metastases, previous treatment with a KRAS G12D inhibitor (for later phases), or significant bleeding recently.Check my eligibility
What is being tested?
The study is testing MRTX1133's safety and effectiveness on various types of solid tumors with the KRAS G12D mutation. It's an early-stage trial to figure out the right dose and see how well it works across different stages: first in any tumor size then focusing on measurable ones.See study design
What are the potential side effects?
Since this is an early-phase trial for MRTX1133, detailed side effects are not yet fully known but may include typical reactions to cancer drugs such as nausea, fatigue, blood count changes, liver function alterations, and potential risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer has a KRAS G12D mutation.
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My cancer cannot be removed by surgery or has spread to other parts.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

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 1/1b: Number of patients who experience a treatment-related adverse event
Phase 1: Number of Patients who Experience Dose-Limiting Toxicity
Phase 2: Duration of response (DOR)
+3 more
Secondary outcome measures
Apparent total plasma clearance when dosed orally (CL/F)
Apparent volume of distribution when dosed orally (Vz/F)
Area under plasma concentration versus time curve (AUC)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2Experimental Treatment1 Intervention
MRTX1133 recommended Phase 2 dose administered to separate cohorts of patients with selected solid tumor malignancies with KRAS G12D mutation to include the following: NSCLC, PDAC, CRC, Other Solid Tumors
Group II: Phase 1/1BExperimental Treatment1 Intervention
Dose Escalation/Evaluation

Find a Location

Who is running the clinical trial?

Mirati Therapeutics Inc.Lead Sponsor
70 Previous Clinical Trials
7,819 Total Patients Enrolled
Hirak Der-Torossian, MDStudy DirectorMirati Therapeutics Inc.
3 Previous Clinical Trials
813 Total Patients Enrolled
Vicky KangStudy DirectorMirati Therapeutics Inc.

Media Library

MRTX1133 (KRAS G12D Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05737706 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Phase 1/1B, Phase 2
Non-Small Cell Lung Cancer Clinical Trial 2023: MRTX1133 Highlights & Side Effects. Trial Name: NCT05737706 — Phase 1 & 2
MRTX1133 (KRAS G12D Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05737706 — 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 still vacancies for participants in this trial?

"This clinical trial is currently recruiting, as reported on clinicaltrials.gov. It first appeared online in March 10th 2023 and has been recently updated on July 3rd of the same year."

Answered by AI

How many individuals are currently participating in this experimentation?

"Indeed, the details shared on clinicaltrials.gov point to this ongoing medical trial as actively searching for participants. This study was initially posted on March 10th 2023 and most recently updated on March 7th 2023; it is currently recruiting 304 patients from one location."

Answered by AI

Who else is applying?

What site did they apply to?
SCRI - TN Oncology Nashville Drug Development Unit Clinic
Memorial Sloan Kettering Cancer Center
Yale University, Yale Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

Why did patients apply to this trial?

KRASG12D mutation that’s driving my cancer would be a great fit for your trial.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
2023. "Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05737706.
All > Colorectal Cancer Glendale
~257 spots leftby Aug 2026
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