Clinical trial · Interventional
Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
Phase 1/1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
NCT07349537CI-TRIAL-00117489recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.
Conditions
Conditions (10)
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 Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| CRC | Colorectal Carcinoma | ALIAS | 0.90 |
| Lung Cancer (NSCLC) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Ductal Adenocarcinoma (PDAC) | Pancreatic Ductal Adenocarcinoma |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Drug | Cetuximab | ALIAS |
| daraxonrasib | Drug | — | UNRESOLVED |
| RMC-5127 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A: RMC-5127 Monotherapy
- description
- Dose Escalation and Dose Expansion
- interventionNames
- Drug: RMC-5127
- type
- EXPERIMENTAL
- label
- Arm B: RMC-5127 + Daraxonrasib Combination
- description
- Dose Escalation and Dose Expansion
- interventionNames
- Drug: RMC-5127
- Drug: daraxonrasib
- type
- EXPERIMENTAL
- label
- Arm C: RMC-5127 + Cetuximab Combination
- description
- Dose Escalation and Dose Expansion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 18 years old and has provided informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Pathologically documented, locally advanced or metastatic KRAS G12V-mutated solid tumor malignancy. * Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage. * Measurable per RECIST v1.1 * Adequate organ function (bone marrow, liver, kidney, coagulation). * Able to take oral medications. Exclusion Criteria: * Primary central nervous system (CNS) tumors * Prior therapy with KRAS G12V inhibitor or direct RAS-targeted therapy (eg. degraders and/or inhibitors). * Any conditions that may affect the ability to take or absorb study drug. * Major surgery within 28 days prior to receiving study drug(s). * Patient is unable or unwilling to comply with protocol-required study visits or procedures.
References
Publications (0)
Data not yet available
No reference posted for this study.