Clinical trial · Interventional
Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)
A Randomized Phase 3 Study of MRTX849 in Combination With Cetuximab Versus Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation With Disease Progression On or After Standard First-Line Therapy
NCT04793958CI-TRIAL-00119102active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.
Conditions
Conditions (2)
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 Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Biological | Cetuximab | ALIAS |
| FOLFIRI Regimen | Drug | FOLFIRI Regimen | ALIAS |
| mFOLFOX6 Regimen | Drug | — | UNRESOLVED |
| MRTX849 | Drug | Adagrasib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MRTX849 + Cetuximab
- interventionNames
- Drug: MRTX849
- Biological: Cetuximab
- type
- ACTIVE_COMPARATOR
- label
- mFOLFOX6 or FOLFIRI
- interventionNames
- Drug: mFOLFOX6 Regimen
- Drug: FOLFIRI Regimen
Primary outcomes (2)
- measure
- Overall Survival (OS)
- timeFrame
- 30 months
- description
- Defined as time from date of randomization to date of death due to any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue. * Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment. Exclusion Criteria: * Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510). * Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab). * Active brain metastasis
References
Publications (1)
- DERIVEDDeming DA. Development of KRAS Inhibitors and Their Role for Metastatic Colorectal Cancer. J Natl Compr Canc Netw. 2025 Jan 3;23(1):e247067. doi: 10.6004/jnccn.2024.7067. PMID 39752885