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

Last updated: April 24, 2025
Sponsor: Alterome Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Cancer

Adenocarcinoma

Treatment

ALTA3263

Clinical Study ID

NCT06835569
3263-001
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed diagnosis of a solid tumor malignancy harboring a KRASmutation identified through molecular testing (NGS- or PCR-based) with a ClinicalLaboratory Improvement Amendments-certified (or equivalent) diagnostic test.

  • Unresectable or metastatic disease.

  • Progressed on, intolerant to, or declined prior standard-of-care therapy (includingtargeted therapy, if applicable) appropriate to tumor type and stage

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

  • Adequate organ function

Exclusion

Exclusion Criteria:

  • Prior treatment with a KRAS inhibitor, certain exceptions are described in the fullstudy protocol

  • Known condition that prohibits the ability to swallow or absorb an oral medication.

Other inclusion/exclusion criteria may apply.

Study Design

Total Participants: 130
Treatment Group(s): 1
Primary Treatment: ALTA3263
Phase: 1
Study Start date:
March 05, 2025
Estimated Completion Date:
August 31, 2029

Study Description

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, and aims to find the best dose. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.

Connect with a study center

  • Research Site

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Research Site

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Research Site

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Research Site

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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