Clinical trial · Interventional
Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
NCT05737706CI-TRIAL-00088177terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Formulation challenges
Summary
Brief summary (as posted)
A Phase 1/2 study of MRTX1133 in solid tumors harboring a KRAS G12D 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 Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Colo-rectal Cancer | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRTX1133 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1/1B
- description
- Dose Escalation/Evaluation
- interventionNames
- Drug: MRTX1133
- type
- EXPERIMENTAL
- label
- Phase 2
- description
- MRTX1133 recommended Phase 2 dose administered to separate cohorts of patients with selected solid tumor malignancies with KRAS G12D mutation to include the following: NSCLC, PDAC, CRC, Other Solid Tumors
- interventionNames
- Drug: MRTX1133
Primary outcomes (6)
- measure
- Phase 1: Number of Patients who Experience Dose-Limiting Toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of a solid tumor malignancy harboring KRAS G12D mutation in tumor tissue or ctDNA. * Unresectable or metastatic disease. * Patients must have received standard therapies appropriate for their tumor type and stage; first-line treatment for PDAC for certain cohorts. * Presence of tumor lesions to be evaluated per RECIST v1.1: 1. in the Phase 1 dose escalation cohorts, patients must have measurable or evaluable disease. 2. in the Phase 1b and Phase 2 cohorts, patients must have measurable disease. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function. * Age ≥ 18 years Exclusion Criteria: * Active brain metastases or carcinomatous meningitis. * Prior treatment with a KRAS G12D inhibitor (Phase 1b \& Phase 2 only). * History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment. * 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 oral medications. * History of malignant small bowel obstruction. * Cardiac abnormalities.
References
Publications (0)
Data not yet available
No reference posted for this study.