Solid TumorPhase 1NCT05737706
Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
A Phase 1 study testing MRTX1133 in people with Solid Tumor and Advanced Solid Tumor, run by Mirati Therapeutics Inc. at 14 sites in United States.
Trial summary
A Phase 1/2 study of MRTX1133 in solid tumors harboring a KRAS G12D mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Advanced Solid Tumor, Non-small Cell Lung Cancer
- What is being tested?
- MRTX1133
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 14 sitesUnited States
- Study dates
- 6 Mar 2023to 10 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of a solid tumor malignancy harboring KRAS G12D mutation in tumor tissue or ctDNA.
- Unresectable or metastatic disease.
- Patients must have received standard therapies appropriate for their tumor type and stage; first-line treatment for PDAC for certain cohorts.
- Presence of tumor lesions to be evaluated per RECIST v1.1:
- in the Phase 1 dose escalation cohorts, patients must have measurable or evaluable disease.
- in the Phase 1b and Phase 2 cohorts, patients must have measurable disease.
Show all 9Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function.
- Age ≥ 18 years
Who cannot join
- Active brain metastases or carcinomatous meningitis.
- Prior treatment with a KRAS G12D inhibitor (Phase 1b \& Phase 2 only).
- History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment.
- History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow oral medications.
- History of malignant small bowel obstruction.
- Cardiac abnormalities.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Local Institution - 306
Baltimore, Maryland, 21231
Local Institution - 308
Boston, Massachusetts, 02114 3117
Local Institution - 310
Boston, Massachusetts, 02215
Local Institution - 305
Fairfax, Virginia, 22031
Local Institution - 314
Grand Rapids, Michigan, 49546
Local Institution - 302
Houston, Texas, 77030
Local Institution - 301
Lady Lake, Florida, 32159 8987
Local Institution - 303
Nashville, Tennessee, 37203
Local Institution - 309
New Haven, Connecticut, 06520 8028
Local Institution - 312
New York, New York, 10065 6800
Local Institution - 311
Phoenix, Arizona, 85054
Local Institution - 304
San Antonio, Texas, 78229 3307
Local Institution - 313
San Antonio, Texas, 78229
Local Institution - 307
Seattle, Washington, 98109 1023
About this study
Official title: A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
A Phase 1/2 study of MRTX1133 in solid tumors harboring a KRAS G12D mutation.
Read the detailed description
This first-in-human clinical trial will begin with an exploration of MRTX1133 dose and regimen. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure collection of sufficient safety and PK information, and early evidence of clinical activity are available to recommend Phase 2 regimens. In Phase 2, separate cohorts of patients by histological diagnosis and/or baseline characteristics will be evaluated for the clinical activity and efficacy of MRTX1133.
This study was terminated prior to phase 2 initiating. Only phase 1 of the study was conducted.
- Conditions
- Solid Tumor, Advanced Solid Tumor, Non-small Cell Lung Cancer, Colo-rectal Cancer, Pancreatic Adenocarcinoma
- Being tested
- MRTX1133
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, colorectal cancer, CRC, PDAC, KRAS, G12D, Solid Tumor, Advanced Solid Tumor, Malignant, Pancreatic Cancer, Pancreatic Adenocarcinoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colonic Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRTX1133Drug
KRAS G12D Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Phase 1/1B | Experimental | Dose Escalation/Evaluation Receives: Drug: MRTX1133 |
| Phase 2 | Experimental | 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 Receives: Drug: MRTX1133 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Number of Patients who Experience Dose-Limiting Toxicity
Measured: 21 Days
Phase 1/1b: Number of patients who experience a treatment-related adverse event
Measured: Up to 2 years
Phase 2: Objective response rate (ORR)
Measured: 2 years
Phase 2: Duration of response (DOR)
Measured: 2 years
Phase 2: Progression free survival (PFS)
Measured: 2 years
Phase 2: Overall survival (OS)
Measured: 2 years
Secondary outcomes (6)
Area under plasma concentration versus time curve (AUC)
Measured: up to 4 days
Time to achieve maximal plasma concentration (Tmax)
Measured: up to 4 days
Maximum observed plasma concentration (Cmax)
Measured: up to 4 days
Terminal elimination half-life (t1/2)
Measured: up to 4 days
Apparent total plasma clearance when dosed orally (CL/F)
Measured: up to 4 days
Apparent volume of distribution when dosed orally (Vz/F)
Measured: up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start6 Mar 2023
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Why it stopped: Formulation challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirati Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737706
- Sponsor's protocol ID
- CA246-0005
- Other IDs
- CA246-0005, 1133-001
- Status last verified
- Apr 2025
- First submitted
- 10 Feb 2023
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
- ClinicalTrials.gov ID
- NCT05737706
- Acronym / sponsor ID
- CA246-0005
- Conditions
- Solid Tumor, Advanced Solid Tumor, Non-small Cell Lung Cancer, Colo-rectal Cancer, Pancreatic Adenocarcinoma
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, colorectal cancer, CRC, PDAC, KRAS, G12D, Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Formulation challenges
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Mirati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1/2 study of MRTX1133 in solid tumors harboring a KRAS G12D mutation.
Detailed description
This first-in-human clinical trial will begin with an exploration of MRTX1133 dose and regimen. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure collection of sufficient safety and PK information, and early evidence of clinical activity are available to recommend Phase 2 regimens. In Phase 2, separate cohorts of patients by histological diagnosis and/or baseline characteristics will be evaluated for the clinical activity and efficacy of MRTX1133.
This study was terminated prior to phase 2 initiating. Only phase 1 of the study was conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1/1B | Experimental | Drug: MRTX1133Dose Escalation/Evaluation |
| Phase 2 | Experimental | Drug: MRTX1133MRTX1133 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed diagnosis of a solid tumor malignancy harboring KRAS G12D mutation in tumor tissue or ctDNA.
- Unresectable or metastatic disease.
- Patients must have received standard therapies appropriate for their tumor type and stage; first-line treatment for PDAC for certain cohorts.
- Presence of tumor lesions to be evaluated per RECIST v1.1:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (6 listed)
- Active brain metastases or carcinomatous meningitis.
- Prior treatment with a KRAS G12D inhibitor (Phase 1b \& Phase 2 only).
- History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment.
- History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow oral medications.
- History of malignant small bowel obstruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRTX1133KRAS G12D Inhibitor | Drug | Phase 1/1B, Phase 2 |
Primary outcome
Phase 1: Number of Patients who Experience Dose-Limiting Toxicity
Time frame: 21 Days
Phase 1/1b: Number of patients who experience a treatment-related adverse event
Time frame: Up to 2 years
Phase 2: Objective response rate (ORR)
Time frame: 2 years
Phase 2: Duration of response (DOR)
Time frame: 2 years
Phase 2: Progression free survival (PFS)
Time frame: 2 years
Phase 2: Overall survival (OS)
Time frame: 2 years
6 secondary outcomes
Area under plasma concentration versus time curve (AUC)
Time frame: up to 4 days
Time to achieve maximal plasma concentration (Tmax)
Time frame: up to 4 days
Maximum observed plasma concentration (Cmax)
Time frame: up to 4 days
Terminal elimination half-life (t1/2)
Time frame: up to 4 days
Apparent total plasma clearance when dosed orally (CL/F)
Time frame: up to 4 days
Apparent volume of distribution when dosed orally (Vz/F)
Time frame: up to 4 days
Results and safety
The study was stopped early (reason given: Formulation challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRTX1133 in people with Solid Tumor and Advanced Solid Tumor, run by Mirati Therapeutics Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Formulation challenges). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Number of Patients who Experience Dose-Limiting Toxicity (time frame: 21 Days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.