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

Last updated: July 14, 2026
Sponsor: Alterome Therapeutics, Inc.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Endometrial Cancer

Prostate Disorders

Prostate 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

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Research Site

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • Research Site

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Research Site

    Caen, 14000
    France

    Site Not Available

  • Research Site

    Villejuif, 94800
    France

    Site Not Available

  • Research Site

    Kyoto, 606-8507
    Japan

    Site Not Available

  • Research Site

    Tokyo, 135-8550
    Japan

    Site Not Available

  • Research Site

    Seoul, 13620
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Seoul, 06591
    South Korea

    Site Not Available

  • Research Site

    Seoul 1835848, 06351
    South Korea

    Active - Recruiting

  • Research Site

    Barcelona, 08908
    Spain

    Site Not Available

  • Research Site

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Research Site

    Madrid, 28023
    Spain

    Site Not Available

  • Research Site

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • Research Site

    Taipei, 100
    Taiwan

    Site Not Available

  • Research Site

    Taipei 1668341, 10449
    Taiwan

    Active - Recruiting

  • Research Site

    London, W1G 6AD
    United Kingdom

    Site Not Available

  • Research Site

    London 2643743, W1G 6AD
    United Kingdom

    Active - Recruiting

  • Research Site

    Manchester, M10 4BX
    United Kingdom

    Site Not Available

  • Research Site

    Newcastle upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • Research Site

    Sutton, SM2 5PT
    United Kingdom

    Site Not Available

  • Research Site

    La Jolla, California 92093
    United States

    Site Not Available

  • Research Site

    Denver, Colorado 80218
    United States

    Site Not Available

  • Research Site

    Sarasota, Florida 34232
    United States

    Site Not Available

  • Research Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Research Site

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • Research Site

    St Louis, Missouri 63110
    United States

    Site Not Available

  • Research Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Research Site #2

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Research Site

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • Research Site

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Research Site

    Madison, Wisconsin 53792
    United States

    Site Not Available

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