Clinical trial · Interventional
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
A Phase 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations
NCT06835569CI-TRIAL-00114240recruitingPhase 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)
The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.
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 Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| CRC (Colorectal Cancer) | Colorectal Carcinoma | ALIAS | 0.85 |
| NSCLC (Non-small Cell Lung Cancer) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| PDAC - Pancreatic Ductal Adenocarcinoma | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALTA3263 | Drug | — | UNRESOLVED |
| cetuximab | Drug | Cetuximab | ALIAS |
| GnP | Drug | — | UNRESOLVED |
| mFOLFIRINOX | Drug | — | UNRESOLVED |
| mFOLFOX6 | Drug | — | UNRESOLVED |
| Midazolam | Drug | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Pemetrexed + Cisplatin /Carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (10)
- type
- EXPERIMENTAL
- label
- ALTA3263 monotherapy
- description
- ALTA3263 will be administered continuously at a protocol-defined dose based on cohort assignment
- interventionNames
- Drug: ALTA3263
- type
- EXPERIMENTAL
- label
- ALTA3263 in combination with cetuximab
- description
- ALTA3263 in combination with cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment
- interventionNames
- Drug: ALTA3263
- Drug: cetuximab
- type
- EXPERIMENTAL
- label
- ALTA3263 in combination with mFOLFOX6 plus cetuximab
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 a KRAS mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test. * Unresectable or metastatic disease. * Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function Exclusion Criteria: * Prior treatment with a KRAS inhibitor, certain exceptions are described in the full study protocol * Known condition that prohibits the ability to swallow or absorb an oral medication. Other inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.