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Investigating ALTA3263 for advanced solid tumors with KRAS mutations

A Phase 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations

PHASE1 · Alterome Therapeutics, Inc. · NCT06835569

This study is testing a new oral medication called ALTA3263 to see if it is safe and effective for adults with advanced solid tumors that have KRAS mutations.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment188 (estimated)
Ages18 Years and up
SexAll
SponsorAlterome Therapeutics, Inc. (industry)
Locations12 sites (Orlando, Florida and 11 other locations)
Trial IDNCT06835569 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of ALTA3263, an oral KRAS isoform-selective inhibitor, in adults with advanced solid tumors that have KRAS mutations. It is an open-label, multicenter Phase 1/1b study designed to assess the pharmacokinetics and preliminary clinical activity of the drug. The study consists of two parts: a dose escalation phase to determine the optimal dose and a dose expansion phase to further evaluate its effects. Participants will be closely monitored for safety and treatment response.

Who should consider this trial

Good fit: Ideal candidates include adults with unresectable or metastatic solid tumors that have confirmed KRAS mutations and have progressed on or are intolerant to prior therapies.

Not a fit: Patients who have previously received treatment with a KRAS inhibitor or have conditions that prevent them from taking oral medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new targeted therapy option for patients with advanced solid tumors harboring KRAS mutations.

How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating that this approach may be effective, though this specific study is exploring a novel agent.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Orlando, Florida and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Cancer, PDAC - Pancreatic Ductal Adenocarcinoma, NSCLC, CRC, Advanced Solid Tumors, KRAS mutation, Non-small cell lung cancer, Colorectal cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.