Advanced Solid TumorPhase 1NCT05178888
Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16)
A Phase 1 study testing MRTX849 and Palbociclib in people with Advanced Solid Tumor, run by Mirati Therapeutics Inc. at 4 sites in United States.
Trial summary
This study will evaluate the safety and clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- MRTX849 and Palbociclib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Jan 2022to 30 Dec 2024
- 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 KRAS G12C mutation
- Unresectable or metastatic disease.
- No available treatment with curative intent
- Adequate organ function
Who cannot join
- History of significant toxicity on prior KRAS G12C or CDK4/6 inhibitor therapies
- History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter the absorption of study treatment or result in an inability to swallow
- Other active cancer
- Cardiac abnormalities
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Local Institution - 802
Houston, Texas, 77030
Local Institution - 803
Nashville, Tennessee, 37203
Local Institution - 804
Orlando, Florida, 32827
Local Institution - 801
San Antonio, Texas, 78229
About this study
Official title: A Phase 1/1b Trial of MRTX849 in Combination With Palbociclib in Patients With Advanced Solid Tumors With KRAS G12C Mutation
This study will evaluate the safety and clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation.
Read the detailed description
This study will evaluate the pharmacokinetics and preliminary clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and palbociclib is a small molecule inhibitor of CDK 4 and 6.
- Conditions
- Advanced Solid Tumor
- Being tested
- MRTX849, Palbociclib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRTX849Drug
Also called KRAS G12C, adagrasib
KRAS G12C inhibitor
PalbociclibDrug
Also called IBRANCE
CDK 4 and 6 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Dose escalation of MRTX849 and palbociclib to determine maximum tolerated dose in combination. Receives: Drug: MRTX849; Drug: Palbociclib |
| Dose Expansion | Experimental | Expansion cohorts may be implemented to ensure sufficient safety experience, pharmacokinetic data and early evidence of clinical activity of MRTX in combination with palbociclib. Receives: Drug: MRTX849; Drug: Palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the number of patients with treatment emergent adverse events of the combination regimen in patients with advanced solid tumor malignancies with KRAS G12C mutation.
Number of participants with treatment emergent adverse events
Measured: 24 months
Evaluate Pharmacokinetics of the combination regimen
Plasma concentration
Measured: 24 months
Establish Maximum Tolerated Dose
Number of patients with dose limiting toxicity
Measured: 24 months
Evaluate preliminary clinical activity of the combination regimen
Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start20 Jan 2022
- Primary completion15 Jun 2023
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- 11 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
- NCT05178888
- Sponsor's protocol ID
- CA239-0018
- Other IDs
- CA239-0018, 849-016
- Status last verified
- Feb 2025
- First submitted
- 1 Dec 2021
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b Trial of MRTX849 in Combination With Palbociclib in Patients With Advanced Solid Tumors With KRAS G12C Mutation
- ClinicalTrials.gov ID
- NCT05178888
- Acronym / sponsor ID
- CA239-0018
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Mirati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 5 Jan 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 study will evaluate the safety and clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation.
Detailed description
This study will evaluate the pharmacokinetics and preliminary clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and palbociclib is a small molecule inhibitor of CDK 4 and 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: MRTX849, Drug: PalbociclibDose escalation of MRTX849 and palbociclib to determine maximum tolerated dose in combination. |
| Dose Expansion | Experimental | Drug: MRTX849, Drug: PalbociclibExpansion cohorts may be implemented to ensure sufficient safety experience, pharmacokinetic data and early evidence of clinical activity of MRTX in combination with palbociclib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
- Unresectable or metastatic disease.
- No available treatment with curative intent
- Adequate organ function
Key exclusion criteria (4 listed)
- History of significant toxicity on prior KRAS G12C or CDK4/6 inhibitor therapies
- History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter the absorption of study treatment or result in an inability to swallow
- Other active cancer
- Cardiac abnormalities
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 |
|---|---|---|
| MRTX849Also: KRAS G12C, adagrasibKRAS G12C inhibitor | Drug | Dose Escalation, Dose Expansion |
| PalbociclibAlso: IBRANCECDK 4 and 6 inhibitor | Drug | Dose Escalation, Dose Expansion |
Primary outcome
Characterize the number of patients with treatment emergent adverse events of the combination regimen in patients with advanced solid tumor malignancies with KRAS G12C mutation.
Time frame: 24 months
Number of participants with treatment emergent adverse events
Evaluate Pharmacokinetics of the combination regimen
Time frame: 24 months
Plasma concentration
Establish Maximum Tolerated Dose
Time frame: 24 months
Number of patients with dose limiting toxicity
Evaluate preliminary clinical activity of the combination regimen
Time frame: 24 months
Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 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
4 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 MRTX849 and Palbociclib in people with Advanced Solid Tumor, run by Mirati Therapeutics Inc. at 4 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Characterize the number of patients with treatment emergent adverse events of the combination regimen in patients with advanced solid tumor malignancies with KRAS G12C mutation. (time frame: 24 months). The study lists 4 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 11 Feb 2025.