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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

Who can join

Ages 18 and older · All sexes

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.

About the study

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

What is being tested

• ALTA3263 (drug)
• cetuximab (drug)
• mFOLFOX6 (drug)
• Pembrolizumab (drug)
• Pemetrexed + Cisplatin /Carboplatin (drug)
• mFOLFIRINOX (drug)

Sponsor: Alterome Therapeutics, Inc. · Participants: 448 · Started: Mar 5, 2025

Contact the study team

• Alterome Clinical Trial Contact Center · Phone: 619-768-8189

Official record on ClinicalTrials.gov — NCT06835569

Locations in the U.S.

Conditions

• Cancer (all types)
• Non-Small Cell Lung Cancer
• Colorectal Cancer
• Pancreatic Cancer
• Metastatic Cancer
• Lung Cancer
• Colon Cancer

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.