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RecruitingPhase 1NCT06835569
Official study title

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

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedALTA3263 and cetuximab

Plus 6 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 26, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?14 U.S. locations

Locations may change over time.

Who runs it?Alterome Therapeutics, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Alterome Therapeutics, Inc.
Interventions being studied
Drug: ALTA3263; Drug: cetuximab; Drug: mFOLFOX6; Drug: Pembrolizumab; Drug: Pemetrexed + Cisplatin /Carboplatin; Drug: mFOLFIRINOX; Drug: GnP; Drug: Midazolam
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Biomarkers
KRAS→
Treatment approach
Immunotherapy→Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SiteOrlando, Florida
  • Research SiteTampa, Florida
  • Research SiteBoston, Massachusetts
  • Research SiteBoston, Massachusetts
  • Research SiteSt Louis, Missouri
  • Research SiteNew York, New York
  • Research SiteNew York, New York
  • Research SiteNew York, New York
  • Research SiteDurham, North Carolina
  • Research SiteNashville, Tennessee
  • Research SiteHouston, Texas
  • Research Site #2San Antonio, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 26, 2026. Always confirm current availability with the study team.

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