Advanced CancerNCT05162443
Expanded Access of Adagrasib (MRTX849) in Patients With Advanced Solid Tumors Who Have a KRAS G12C Mutation
A study testing adagrasib (MRTX849) in people with Advanced Cancer and Metastatic Cancer, run by Bristol-Myers Squibb at 11 sites in United States.
Trial summary
The objective of this EAP is to provide expanded access of adagrasib (MRTX849) to patients with previously treated advanced solid tumors harboring a KRAS G12C mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Metastatic Cancer, Malignant Neoplasm
- What is being tested?
- adagrasib (MRTX849)
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 11 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of an advanced/metastatic solid tumor
- Confirmed presence of a KRASG12C mutation
- Ineligible for an ongoing clinical trial of MRTX849
- No available or not eligible for standard of care treatment
- Adequate organ function
- CNS Metastases (within set parameters) are allowed
- ECOG performance status of ≤ 2
Who cannot join
- History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of MRTX849 treatment or result in inability to swallow
- Prior therapy targeting a KRAS G12C mutation
- Other active cancer
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Lehigh Valley Cancer Institute
Allentown, Pennsylvania, 18103
Piedmont Cancer Institute
Atlanta, Georgia, 30318
Hartford Hospital
Hartford, Connecticut, 06106
Lumi Research
Kingwood, Texas, 77339
Renown Health
Reno, Nevada, 89502
Seattle Integrative Cancer Center
Renton, Washington, 98057
Virginia Cancer Institute
Richmond, Virginia, 23230
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
California Pacific Medical Center
San Francisco, California, 94115
Providence Medical Group Santa Rosa - Cancer Center
Santa Rosa, California, 95403
Swedish Cancer Institute
Seattle, Washington, 98104
About this study
Official title: Expanded Access Use of Adagrasib (MRTX849) for the Treatment of Patients With Advanced Solid Tumors With a KRAS G12C Mutation
The objective of this EAP is to provide expanded access of adagrasib (MRTX849) to patients with previously treated advanced solid tumors harboring a KRAS G12C mutation.
- Conditions
- Advanced Cancer, Metastatic Cancer, Malignant Neoplasm
- Being tested
- adagrasib (MRTX849)
- Keywords
- adagrasib, expanded access
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adagrasib (MRTX849)Drug
adagrasib (MRTX849) will be administered orally twice daily in a continuous regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- 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
- NCT05162443
- Sponsor's protocol ID
- CA239-0067
- Other IDs
- 849-EAP-001
- Status last verified
- Aug 2025
- First submitted
- 3 Dec 2021
- Last updated
- 26 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Use of Adagrasib (MRTX849) for the Treatment of Patients With Advanced Solid Tumors With a KRAS G12C Mutation
- ClinicalTrials.gov ID
- NCT05162443
- Acronym / sponsor ID
- CA239-0067
- Conditions
- Advanced Cancer, Metastatic Cancer, Malignant Neoplasm
- Keywords
- adagrasib, expanded access
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- First posted
- 17 Dec 2021 (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.
The objective of this EAP is to provide expanded access of adagrasib (MRTX849) to patients with previously treated advanced solid tumors harboring a KRAS G12C mutation.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed diagnosis of an advanced/metastatic solid tumor
- Confirmed presence of a KRASG12C mutation
- Ineligible for an ongoing clinical trial of MRTX849
- No available or not eligible for standard of care treatment
- Adequate organ function
Key exclusion criteria (3 listed)
- History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of MRTX849 treatment or result in inability to swallow
- Prior therapy targeting a KRAS G12C mutation
- Other active cancer
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 |
|---|---|---|
| adagrasib (MRTX849)adagrasib (MRTX849) will be administered orally twice daily in a continuous regimen | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- BMS Clinical Trial InformationLink 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
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adagrasib (MRTX849) in people with Advanced Cancer and Metastatic Cancer, run by Bristol-Myers Squibb at 11 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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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.
Are results available for this study?
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.
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 26 Aug 2025.