A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors

Last updated: April 25, 2025
Sponsor: Alterome Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Metastatic Cancer

Breast Cancer

Endometrial Cancer

Treatment

ALTA2618

Clinical Study ID

NCT06533059
2618-001
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed diagnosis of a solid tumor malignancy harboring AKT1 E17Kmutation 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

  • Evaluable or measurable disease per RECIST v1.1

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

  • Adequate organ function.

Exclusion

Exclusion Criteria:

  • Prior treatment with PI3K and/or mTOR inhibitors

  • Patients known to have KRAS, NRAS, HRAS, or BRAF genomic alterations in their tumor

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

Other inclusion/exclusion criteria may apply.

Study Design

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: ALTA2618
Phase: 1
Study Start date:
August 22, 2024
Estimated Completion Date:
December 29, 2027

Study Description

This is an open-label, multicenter, Phase 1/1b study of ALTA2618, a mutant-selective and orally bioavailable AKT1 E17K inhibitor, in adults with AKT1 E17K-mutant solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of ALTA2618, 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

    Blacktown, New South Wales 2148
    Australia

    Active - Recruiting

  • Research Site

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • Research Site

    Malvern, Victoria 3144
    Australia

    Active - Recruiting

  • Research Site

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Research Site

    Kyoto, 606-8507
    Japan

    Active - Recruiting

  • Research Site

    Shizuoka, 411-8777
    Japan

    Active - Recruiting

  • Research Site

    Tokyo, 135-8550
    Japan

    Active - Recruiting

  • Research Site

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Barcelona, 08023
    Spain

    Active - Recruiting

  • Research Site

    Madrid, 28040
    Spain

    Active - Recruiting

  • Research Site

    Changhua, 500
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei, 10449
    Taiwan

    Active - Recruiting

  • Research Site

    La Jolla, California 92093
    United States

    Active - Recruiting

  • Research Site

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Research Site

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Research Site

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Research Site

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Research Site

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Research Site

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Research Site

    Mineola, New York 11501
    United States

    Active - Recruiting

  • Research Site

    New York, New York 10016
    United States

    Active - Recruiting

  • Research Site

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Research Site

    Dallas, Texas 75251
    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 #2

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Research Site

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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