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A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations

NCT06835569 · Alterome Therapeutics, Inc.
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Official title
A Phase 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 448 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-05
Estimated completion: 2029-08
Last updated: 2026-06-10
Interventions
Drug: ALTA3263Drug: cetuximabDrug: mFOLFOX6Drug: PembrolizumabDrug: Pemetrexed + Cisplatin /CarboplatinDrug: mFOLFIRINOXDrug: GnPDrug: Midazolam
Primary outcomes
  • Adverse Events (Up to 39 months)
  • Dose Limiting Toxicities (21 days)
Sponsor
Alterome Therapeutics, Inc. · industry
Contacts & investigators
ContactAlterome Clinical Trial Contact Center · contact · clinical.trials@alterome.com · 619-768-8189
InvestigatorStudy Medical Director · study_director, Alterome Therapeutics
All locations (12)
Research SiteRecruiting
Orlando, Florida, United States
Research SiteRecruiting
Boston, Massachusetts, United States
Research SiteRecruiting
Boston, Massachusetts, United States
Research SiteRecruiting
St Louis, Missouri, United States
Research SiteRecruiting
New York, New York, United States
Research SiteRecruiting
New York, New York, United States
Research SiteRecruiting
Durham, North Carolina, United States
Research SiteRecruiting
Nashville, Tennessee, United States
Research SiteRecruiting
Houston, Texas, United States
Research Site #2Recruiting
San Antonio, Texas, United States
Research SiteRecruiting
San Antonio, Texas, United States
Research SiteRecruiting
Fairfax, Virginia, United States
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations · TrialPath