A Phase 1 interventional study of MRTX849 and BI 1701963 in Advanced Cancer, Metastatic Cancer and Malignant Neoplasm of Colon, sponsored by Mirati Therapeutics Inc.. Terminated at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Mirati Therapeutics Inc. · Phase 1, Interventional, and Treatment
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's enrollment of 7 is below the median of 50 across 7,250 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Mirati Therapeutics Inc. is the lead sponsor of 50 studies on the registry; 3 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 4 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dose escalation of MRTX849 and BI 1701963 to determine maximum tolerated dose in combination
Drug: MRTX849 · Drug: BI 1701963
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
Drug: MRTX849 · Drug: BI 1701963
KRAS G12C inhibitor
Also known as: KRAS G12C inhibitor, adagrasib
SOS1 Inhibitor
Also known as: SOS1 Inhibitor
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
Time frame: 20 months
Evaluate Pharmacokinetics of the combination regimen
Blood plasma concentration
Time frame: 20 months
Establish Maximum Tolerated Dose
Number of patients with dose limiting toxicity
Time frame: 12 months
Evaluate preliminary clinical activity of the combination regimen
Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 20 months
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Mirati Therapeutics Inc.