Solid TumorPhase 1NCT05578092
A Phase 1 Study of MRTX0902 in Solid Tumors With Mutations in the KRAS MAPK Pathway
A Phase 1 study testing MRTX0902 and MRTX849 in people with Solid Tumor and Advanced Solid Tumor, run by Mirati Therapeutics Inc. at 18 sites in 2 countries.
Trial summary
This is a Phase 1, 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. 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?
- MRTX0902 and MRTX849
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 2 Dec 2022to 3 Feb 2026
- 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 with any of the following oncogenic mutations detected in tumor tissue or ctDNA by a sponsor-approved test:
- MRTX0902 monotherapy: known KRAS mutations, known annotated recurrent activating SOS1, PTPN11, class III BRAF, or EGFR mutation, or known annotated recurrent inactivating NF1 mutation;
- MRTX0902 and adagrasib combination therapy: KRAS G12C mutation.
- Unresectable or metastatic disease
- No available treatment with curative intent; standard treatment is not available or patient declines
- Presence of tumor lesions to be evaluated per RECIST 1.1. Phase 1 dose escalation, RECIST 1.1 measurable or evaluable disease
Show all 9Show fewer
- Presence of a tumor lesion amenable to mandatory biopsy for pharmacodynamic evaluation at baseline and on-study unless Sponsor-confirmed as medically unsafe or infeasible.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function
Who cannot join
- Active brain metastases or carcinomatous meningitis
- Prior treatment with a KRAS G12C inhibitor (for Phase 1b expansion for MRTX0902 and adagrasib combination).
- History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment.
- Major surgery within 4 weeks of first dose of study treatment
- History of pneumonitis or interstitial lung disease
- Ongoing need for medication with following characteristics: substrate of CYP3A; strong inducer or inhibitor or CYP3A and/or P-gp; strong inhibitors of BRCP and proton pump inhibitors
- Cardiac abnormalities
- History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States17 sites
Local Institution - 001-103
Baltimore, Maryland, 21287
Local Institution - 001-106
Cincinnati, Ohio, 45219-2364
Local Institution - 001-112
Dallas, Texas, 75246-2003
Local Institution - 001-104
Fairfax, Virginia, 22031
Local Institution - 001-122
Fort Worth, Texas, 76104-2154
Local Institution - 001-115
Hackensack, New Jersey, 07601-2191
Local Institution - 001-107
Houston, Texas, 77030
Local Institution - 001-101
Nashville, Tennessee, 37203
Local Institution - 001-102
Nashville, Tennessee, 37203
Local Institution - 001-108
New Haven, Connecticut, 06520
Local Institution - 001-119
Newark, Delaware, 19713-2055
Local Institution - 001-111
Orlando, Florida, 32827-7400
Local Institution - 001-116
Pittsburgh, Pennsylvania, 15232
Local Institution - 001-109
Portland, Oregon, 97239-3011
Local Institution - 001-110
Rochester, Minnesota, 55905-0001
Local Institution - 001-105
Seattle, Washington, 98109
Local Institution - 001-123
Tyler, Texas, 75708-3154
About this study
Official title: A Phase 1 Multiple Expansion Cohort Trial of the SOS1 Inhibitor MRTX0902 in Patients With Advanced Solid Tumors Harboring Mutations in the KRAS MAPK Pathway
This is a Phase 1, 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.
Read the detailed description
This first-in-human clinical trial will begin with an exploration of MRTX0902 dose and regimen. Once safety experience and PK data are available for the monotherapy regimen, dose escalation of the combination of MRTX0902 and adagrasib will be initiated, and will include a separate preliminary food effect assessments on MRTX0902 PK in combination with adagrasib. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure collection of sufficient safety and PK information.
- Being tested
- MRTX0902, MRTX849
- Keywords
- Non Small Cell Lung Cancer, NSCLC, Colorectal Cancer, CRC, EGFR, KRAS, SOS1, Solid Tumor, Advanced Solid Tumor, Malignant
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRTX0902Drug
SOS1 inhibitor
MRTX849Drug
Also called adagrasib (KRAZATI)
KRAS G12C inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Phase 1/1B Monotherapy | Experimental | Dose Escalation/Evaluation Receives: Drug: MRTX0902 |
| Phase 1/1B Combination Therapy | Experimental | Dose Escalation/Evaluation and Food Effect Assessment Receives: Drug: MRTX0902; Drug: MRTX849 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients who Experience Dose-Limiting Toxicity
Measured: 21 Days
Number of patients who experience a treatment-related adverse event
Measured: Up to 2 years
Secondary outcomes (6)
Area under the plasma concentration versus time curve
AUC - MRTX0902 and adagrasib
Measured: Up to 4 days
Time to achieve maximal plasma concentration
Tmax - MRTX0902 and adagrasib
Measured: Up to 4 days
Maximum observed plasma concentration
Cmax - MRTX0902 and adagrasib
Measured: Up to 4 days
Terminal elimination half-life
t1/2 - MRTX0902
Measured: Up to 4 days
Apparent total plasma clearance when dosed orally
CL/F - MRTX0902
Measured: Up to 4 days
Apparent volume of distribution when dosed orally
Vz/F - MRTX0902
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 posted13 Oct 2022
- Study start2 Dec 2022
- Primary completion3 Feb 2026
- Study completion3 Feb 2026
Why it stopped: business objectives have changed
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
- 64 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
- NCT05578092
- Sponsor's protocol ID
- CA247-0004
- Other IDs
- CA247-0004, 0902-001
- Status last verified
- Feb 2026
- First submitted
- 10 Oct 2022
- Last updated
- 19 Feb 2026
- 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 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multiple Expansion Cohort Trial of the SOS1 Inhibitor MRTX0902 in Patients With Advanced Solid Tumors Harboring Mutations in the KRAS MAPK Pathway
- ClinicalTrials.gov ID
- NCT05578092
- Acronym / sponsor ID
- CA247-0004
- Keywords
- Non Small Cell Lung Cancer, NSCLC, Colorectal Cancer, CRC, EGFR, KRAS, SOS1, Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: business objectives have changed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mirati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 3 Feb 2026 (actual)
- Study completion
- 3 Feb 2026 (actual)
- First posted
- 13 Oct 2022 (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.
This is a Phase 1, 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.
Detailed description
This first-in-human clinical trial will begin with an exploration of MRTX0902 dose and regimen. Once safety experience and PK data are available for the monotherapy regimen, dose escalation of the combination of MRTX0902 and adagrasib will be initiated, and will include a separate preliminary food effect assessments on MRTX0902 PK in combination with adagrasib. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure collection of sufficient safety and PK information.
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 Monotherapy | Experimental | Drug: MRTX0902Dose Escalation/Evaluation |
| Phase 1/1B Combination Therapy | Experimental | Drug: MRTX0902, Drug: MRTX849Dose Escalation/Evaluation and Food Effect Assessment |
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 with any of the following oncogenic mutations detected in tumor tissue or ctDNA by a sponsor-approved test:
- Unresectable or metastatic disease
- No available treatment with curative intent; standard treatment is not available or patient declines
- Presence of tumor lesions to be evaluated per RECIST 1.1. Phase 1 dose escalation, RECIST 1.1 measurable or evaluable disease
- Presence of a tumor lesion amenable to mandatory biopsy for pharmacodynamic evaluation at baseline and on-study unless Sponsor-confirmed as medically unsafe or infeasible.
Key exclusion criteria (8 listed)
- Active brain metastases or carcinomatous meningitis
- Prior treatment with a KRAS G12C inhibitor (for Phase 1b expansion for MRTX0902 and adagrasib combination).
- History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment.
- Major surgery within 4 weeks of first dose of study treatment
- History of pneumonitis or interstitial lung disease
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 |
|---|---|---|
| MRTX0902SOS1 inhibitor | Drug | Phase 1/1B Combination Therapy, Phase 1/1B Monotherapy |
| MRTX849Also: adagrasib (KRAZATI)KRAS G12C inhibitor | Drug | Phase 1/1B Combination Therapy |
Primary outcome
Number of Patients who Experience Dose-Limiting Toxicity
Time frame: 21 Days
Number of patients who experience a treatment-related adverse event
Time frame: Up to 2 years
6 secondary outcomes
Area under the plasma concentration versus time curve
Time frame: Up to 4 days
Time to achieve maximal plasma concentration
Time frame: Up to 4 days
Maximum observed plasma concentration
Time frame: Up to 4 days
Terminal elimination half-life
Time frame: Up to 4 days
Apparent total plasma clearance when dosed orally
Time frame: Up to 4 days
Apparent volume of distribution when dosed orally
Time frame: Up to 4 days
Results and safety
The study was stopped early (reason given: business objectives have changed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- 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
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRTX0902 and MRTX849 in people with Solid Tumor and Advanced Solid Tumor, run by Mirati Therapeutics Inc. at 18 sites in 2 countries.
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 8 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 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Puerto Rico. 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: business objectives have changed). 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?
Number of Patients who Experience Dose-Limiting Toxicity (time frame: 21 Days). The study lists 2 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 19 Feb 2026; AzTrials last refreshed its copy on 31 Oct 2026.