Clinical trial · Interventional
A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
NCT06179160CI-TRIAL-00118876recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
| FOLFOX | Drug | FOLFOX Regimen | ALIAS |
| GEMNabP | Drug | — | UNRESOLVED |
| INCA33890 | Drug | — | UNRESOLVED |
| INCB161734 | Drug | — | UNRESOLVED |
| mFOLFIRINOX | Drug | — | UNRESOLVED |
| Retifanlimab | Drug | Retifanlimab | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Part 1a: Dose Escalation monotherapy
- description
- INCB161734 at the protocol-defined dose strength based on cohort assignment.
- interventionNames
- Drug: INCB161734
- type
- EXPERIMENTAL
- label
- Part 1b: Dose Expansion monotherapy
- description
- INCB161734 at the protocol-defined dose strength based on cohort assignment.
- interventionNames
- Drug: INCB161734
- type
- EXPERIMENTAL
- label
- Part 1c: Pharmacodynamic cohort
- description
- INCB161734 at the protocol-defined dose strength based on cohort assignment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥18 years old. * Locally advanced or metastatic solid tumor with KRAS G12D mutation. * For Part 1a and Part 2 Combination Groups 1, 2, and 7: Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, declined available therapies that are known to confer clinical benefit, or no standard available treatment to improve the disease outcome. * Cohort specific requirements aas defined in the protocol. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Prior treatment with any KRAS G12D inhibitor * Known additional invasive malignancy within 1 year of the first dose of study drug * History of organ transplant, including allogeneic stem cell transplantation * Significant, uncontrolled medical condition * History or presence of an ECG abnormality * Inadequate organ function Other protocol-defined Inclusion/Exclusion Criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.