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Recruiting Phase 1 NCT06835569

NCT06835569 A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations

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Clinical Trial Summary
NCT ID NCT06835569
Status Recruiting
Phase Phase 1
Sponsor Alterome Therapeutics, Inc.
Condition Cancer
Study Type INTERVENTIONAL
Enrollment 188 participants
Start Date 2025-03-05
Primary Completion 2029-05

Trial Parameters

Condition Cancer
Sponsor Alterome Therapeutics, Inc.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 188
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-03-05
Completion 2029-05
Interventions
ALTA3263cetuximab

Eligibility Fast-Check

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Brief Summary

The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.

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.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology