Trials / Recruiting
RecruitingNCT06835569
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 188 (estimated)
- Sponsor
- Alterome Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.
Detailed description
This is an open-label, multicenter, Phase 1/1b study of ALTA3263, an orally bioavailable KRAS isoform-selective inhibitor that inhibits multiple mutant forms of KRAS, in adults with advanced solid tumor malignancies with KRAS mutations. This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of ALTA3263 as a monotherapy and as a combination regimen. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.
Conditions
- Cancer
- PDAC - Pancreatic Ductal Adenocarcinoma
- NSCLC (Non-small Cell Lung Cancer)
- CRC (Colorectal Cancer)
- Advanced Solid Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALTA3263 | Oral ALTA3263 tablets will be administered at a protocol-defined dose |
| DRUG | cetuximab | Cetuximab injection for IV use will be administered at a protocol-defined dose |
Timeline
- Start date
- 2025-03-05
- Primary completion
- 2029-05-01
- Completion
- 2029-08-01
- First posted
- 2025-02-19
- Last updated
- 2026-04-03
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06835569. Inclusion in this directory is not an endorsement.