Description:
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.
Clinical Trials /
Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)
NCT04975256
Related Conditions:
- Malignant Solid Tumor
Recruiting Status:
Recruiting
Phase:
Phase 1
Trial Eligibility
Document
Title
- Brief Title: Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)
- Official Title: A Phase 1/1b Trial of MRTX849 in Combination With BI 1701963 in Patients With Advanced Solid Tumors With KRAS G12C Mutation
Clinical Trial IDs
- ORG STUDY ID: 849-014
- NCT ID: NCT04975256
Conditions
- Advanced Cancer
- Metastatic Cancer
- Malignant Neoplasm of Colon
- Malignant Neoplasm of Lung
- Malignant Neoplastic Disease
Interventions
| Drug | Synonyms | Arms |
|---|---|---|
| MRTX849 | KRAS G12C inhibitor, adagrasib | Dose escalation |
| BI 1701963 | SOS1 Inhibitor | Dose escalation |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|---|---|---|
| Dose escalation | Experimental | Dose escalation of MRTX849 and BI 1701963 to determine maximum tolerated dose in combination |
|
| 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 |
|
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| 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 |
| Safety Issue: | |
| Description: | Number of participants with treatment related adverse events |
Secondary Outcome Measures
| Measure: | Evaluate preliminary clinical activity of the combination regimen |
| Time Frame: | 20 months |
| Safety Issue: | |
| Description: | Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Mirati Therapeutics Inc. |
Trial Keywords
- KRAS G12C
- SOS1 Inhibitor
- NSCLC
- CRC
- Non Small Cell Lung Cancer
- Colon Cancer
- Advanced Solid Tumor
- Metastatic Cancer
- Pancreatic Cancer
- adagrasib
Last Updated
September 1, 2021
