Advanced CancerPhase 1NCT04975256
Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)
A Phase 1 study testing MRTX849 and BI 1701963 in people with Advanced Cancer and Metastatic Cancer, run by Mirati Therapeutics Inc. at 4 sites in United States.
Trial summary
This study will evaluate safety, tolerability, drug levels, molecular effects and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors that have 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 of Colon
- What is being tested?
- MRTX849 and BI 1701963
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Jul 2021to 15 Nov 2022
- 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 (phase 1b must be either Non-Small Cell Lung Cancer or Colorectal Cancer)
- Unresectable or metastatic disease
- No available treatment with curative intent
- Adequate organ function
Who cannot join
- 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
- Other active cancer
- Cardiac abnormalities
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
MD Anderson Cancer Center
Houston, Texas, 77030
Next Oncology
San Antonio, Texas, 78229
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase 1/1b Trial of MRTX849 in Combination With BI 1701963 in Patients With Advanced Solid Tumors With KRAS G12C Mutation
This study will evaluate safety, tolerability, drug levels, molecular effects and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors that have a KRAS G12C mutation.
Read the detailed description
This study will evaluate safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and BI 1701963 is a SOS1 pan-KRAS inhibitor.
- Conditions
- Advanced Cancer, Metastatic Cancer, Malignant Neoplasm of Colon, Malignant Neoplasm of Lung, Malignant Neoplastic Disease
- Being tested
- MRTX849, BI 1701963
- Keywords
- KRAS G12C, SOS1 Inhibitor, NSCLC, CRC, Non Small Cell Lung Cancer, Colon Cancer, Advanced Solid Tumor, Metastatic Cancer, Pancreatic Cancer, adagrasib
- Medical subject headings
- Neoplasm Metastasis, Colonic Neoplasms, Lung Neoplasms, Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRTX849Drug
Also called KRAS G12C inhibitor, adagrasib
KRAS G12C inhibitor
BI 1701963Drug
Also called SOS1 Inhibitor
SOS1 Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | Dose escalation of MRTX849 and BI 1701963 to determine maximum tolerated dose in combination Receives: Drug: MRTX849; Drug: BI 1701963 |
| Dose expansion | Experimental | Expansion cohorts in NSCLC and CRC patients to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 in combination with BI 1701963 Receives: Drug: MRTX849; Drug: BI 1701963 |
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 related adverse events
Measured: 20 months
Evaluate Pharmacokinetics of the combination regimen
Blood plasma concentration
Measured: 20 months
Establish Maximum Tolerated Dose
Number of patients with dose limiting toxicity
Measured: 12 months
Secondary outcomes (1)
Evaluate preliminary clinical activity of the combination regimen
Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start28 Jul 2021
- Primary completion2 Nov 2022
- Study completion15 Nov 2022
Why it stopped: The decision was made to terminate this study to further enrollment, as of 08 March 2022. The decision was made primarily due to a change in development strategy.
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.
- 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirati Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Richard Chao, MD, Study director, Mirati Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975256
- Sponsor's protocol ID
- 849-014
- Status last verified
- Dec 2024
- First submitted
- 6 Jul 2021
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. 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 BI 1701963 in Patients With Advanced Solid Tumors With KRAS G12C Mutation
- ClinicalTrials.gov ID
- NCT04975256
- Acronym / sponsor ID
- 849-014
- Conditions
- Advanced Cancer, Metastatic Cancer, Malignant Neoplasm of Colon, Malignant Neoplasm of Lung, Malignant Neoplastic Disease
- Keywords
- KRAS G12C, SOS1 Inhibitor, NSCLC, CRC, Non Small Cell Lung Cancer, Colon Cancer, Advanced Solid Tumor, Metastatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision was made to terminate this study to further enrollment, as of 08 March 2022. The decision was made primarily due to a change in development strategy.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Mirati Therapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 23 Jul 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.
This study will evaluate safety, tolerability, drug levels, molecular effects and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors that have a KRAS G12C mutation.
Detailed description
This study will evaluate safety, tolerability, pharmacokinetics, metabolites, pharmacodynamics and clinical activity of MRTX849 (adagrasib) in combination with BI 1701963 in patients with advanced solid tumors with a KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and BI 1701963 is a SOS1 pan-KRAS inhibitor.
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: BI 1701963Dose escalation of MRTX849 and BI 1701963 to determine maximum tolerated dose in combination |
| Dose expansion | Experimental | Drug: MRTX849, Drug: BI 1701963Expansion cohorts in NSCLC and CRC patients to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of MRTX849 in combination with BI 1701963 |
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 (phase 1b must be either Non-Small Cell Lung Cancer or Colorectal Cancer)
- Unresectable or metastatic disease
- No available treatment with curative intent
- 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 study treatment or result in 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 inhibitor, adagrasibKRAS G12C inhibitor | Drug | Dose escalation, Dose expansion |
| BI 1701963Also: SOS1 InhibitorSOS1 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: 20 months
Number of participants with treatment related adverse events
Evaluate Pharmacokinetics of the combination regimen
Time frame: 20 months
Blood plasma concentration
Establish Maximum Tolerated Dose
Time frame: 12 months
Number of patients with dose limiting toxicity
1 secondary outcome
Evaluate preliminary clinical activity of the combination regimen
Time frame: 20 months
Results and safety
The study was stopped early (reason given: The decision was made to terminate this study to further enrollment, as of 08 March 2022. The decision was made primarily due to a change in development strategy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Richard Chao, MD study director
Mirati Therapeutics
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 BI 1701963 in people with Advanced Cancer and Metastatic Cancer, 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 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: stopped early, as of the sponsor's last update on 16 Dec 2024. 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 was stopped early (reason given: The decision was made to terminate this study to further enrollment, as of 08 March 2022. The decision was made primarily due to a change in development strategy.). 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?
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: 20 months). The study lists 3 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 16 Dec 2024.