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

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

Phase

1

Condition

Endometriosis

Cervical Cancer

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

    Blacktown, New South Wales 2148
    Australia

    Site Not Available

  • Research Site

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Research Site

    Blacktown 2175411, New South Wales 2155400 2148
    Australia

    Active - Recruiting

  • Research Site

    Randwick 2208285, New South Wales 2155400 2031
    Australia

    Active - Recruiting

  • Research Site

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Research Site

    South Brisbane 2207259, Queensland 2152274 4101
    Australia

    Active - Recruiting

  • Research Site

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • Research Site

    Malvern 2158952, Victoria 2145234 3144
    Australia

    Active - Recruiting

  • Research Site

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Research Site

    Nedlands 2064874, Western Australia 2058645 6009
    Australia

    Active - Recruiting

  • Research Site

    Caen 3029241, 14000
    France

    Active - Recruiting

  • Research Site

    Dijon 3021372, 21000
    France

    Active - Recruiting

  • Research Site

    Saint-Herblain, 44805
    France

    Site Not Available

  • Research Site

    Saint-Herblain 2979590, 44805
    France

    Active - Recruiting

  • Research Site

    Villejuif, 94800
    France

    Site Not Available

  • Research Site

    Villejuif 2968705, 94800
    France

    Active - Recruiting

  • Research Site

    Kyoto, 606-8507
    Japan

    Site Not Available

  • Research Site

    Kyoto 1857910, 606-8507
    Japan

    Active - Recruiting

  • Research Site

    Matsuyama, 791-0280
    Japan

    Site Not Available

  • Research Site

    Matsuyama 1926099, 791-0280
    Japan

    Active - Recruiting

  • Research Site

    Shizuoka, 411-8777
    Japan

    Site Not Available

  • Research Site

    Shizuoka 1851717, 411-8777
    Japan

    Active - Recruiting

  • Research Site

    Tokyo, 135-8550
    Japan

    Site Not Available

  • Research Site

    Tokyo 1850147, 135-8550
    Japan

    Active - Recruiting

  • Research Site

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul 1835848, 06591
    South Korea

    Active - Recruiting

  • Research Site

    Barcelona, 08035
    Spain

    Site Not Available

  • Research Site

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Research Site

    Madrid, 28040
    Spain

    Site Not Available

  • Research Site

    Madrid 3117735, 28023
    Spain

    Active - Recruiting

  • Research Site

    Valencia, 46010
    Spain

    Site Not Available

  • Research Site

    Valencia 2509954, 46010
    Spain

    Active - Recruiting

  • Research Site

    Changhua, 500
    Taiwan

    Site Not Available

  • Research Site

    Changhua 1993459, 500
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei, 10449
    Taiwan

    Site Not Available

  • Research Site

    Taipei 1668341, 10449
    Taiwan

    Active - Recruiting

  • Research Site

    London, W1T 7HA
    United Kingdom

    Site Not Available

  • Research Site

    London 2643743, SW3 6JJ
    United Kingdom

    Active - Recruiting

  • Research Site

    Manchester, M10 4BX
    United Kingdom

    Site Not Available

  • Research Site

    Manchester 2643123, M10 4BX
    United Kingdom

    Active - Recruiting

  • Research Site

    Newcastle upon Tyne 2641673, NE7 7DN
    United Kingdom

    Active - Recruiting

  • Research Site

    Sutton 2636503, SM2 5PT
    United Kingdom

    Active - Recruiting

  • Research Site

    La Jolla, California 92093
    United States

    Site Not Available

  • Research Site

    Los Angeles, California 90095
    United States

    Site Not Available

  • Research Site

    La Jolla 5363943, California 5332921 92093
    United States

    Active - Recruiting

  • Research Site

    Los Angeles 5368361, California 5332921 90095
    United States

    Active - Recruiting

  • Research Site

    Denver, Colorado 80218
    United States

    Site Not Available

  • Research Site

    Denver 5419384, Colorado 5417618 80218
    United States

    Active - Recruiting

  • Research Site

    Sarasota, Florida 34232
    United States

    Site Not Available

  • Research Site

    Sarasota 4172131, Florida 4155751 34232
    United States

    Active - Recruiting

  • Research Site

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Research Site

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Active - Recruiting

  • Research Site

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Research Site

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Research Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Research Site

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • Research Site

    Mineola, New York 11501
    United States

    Site Not Available

  • Research Site

    New York, New York 10016
    United States

    Site Not Available

  • Research Site

    Mineola 5127134, New York 5128638 11501
    United States

    Active - Recruiting

  • Research Site

    New York 5128581, New York 5128638 10016
    United States

    Active - Recruiting

  • Research Site

    Maumee, Ohio 43637
    United States

    Site Not Available

  • Research Site

    Maumee 5162137, Ohio 5165418 43637
    United States

    Active - Recruiting

  • Research Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Research Site

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Research Site

    Dallas, Texas 75251
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Research Site #2

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Research Site

    Dallas 4684888, Texas 4736286 75230
    United States

    Site Not Available

  • Research Site

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Research Site

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • Research Site #2

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • Research Site

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Research Site

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Active - Recruiting

  • Research Site

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Research Site

    Madison 5261457, Wisconsin 5279468 53792
    United States

    Active - Recruiting

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