Clinical trial · Interventional
Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)
A Phase 1/1b Trial of MRTX849 in Combination With BI 1701963 in Patients With Advanced Solid Tumors With KRAS G12C Mutation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Malignant Neoplasm of Colon | Malignant Colon Neoplasm | ALIAS | 0.90 |
| Malignant Neoplasm of Lung | Malignant Lung Neoplasm | ALIAS | 0.90 |
| Malignant Neoplastic Disease | Malignant Neoplasm | ALIAS | 0.90 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BI 1701963 | Drug | — | UNRESOLVED |
| MRTX849 | Drug | Adagrasib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose escalation
- description
- Dose escalation of MRTX849 and BI 1701963 to determine maximum tolerated dose in combination
- interventionNames
- Drug: MRTX849
- Drug: BI 1701963
- type
- EXPERIMENTAL
- label
- Dose expansion
- description
- 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
- interventionNames
- Drug: MRTX849
- Drug: BI 1701963
Primary outcomes (3)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available