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New targeted drug shows promise for rare cancer mutation

NCT ID NCT06533059

Disease control Sponsor: Alterome Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This early-stage trial tests a new drug, ALTA2618, in about 110 adults whose advanced solid tumors (like breast or endometrial cancer) have a specific genetic change called AKT1 E17K. The main goals are to check the drug's safety and find the right dose. Participants must have tried other treatments first or not been able to take them.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed diagnosis of a solid tumor malignancy harboring AKT1 E17K 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 * Evaluable or measurable disease per RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function. 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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm cancer endometrial cancer endometrium neoplasm female reproductive system neoplasm metastatic malignant neoplasm neoplasm Neoplasm Metastasis ovarian cancer prostate cancer triple-negative breast carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Breast cancer Cancer Endometrial cancer Metastatic cancer

Contacts and locations

Locations

  • Research Site

    La Jolla, California, 92093, United States

  • Research Site

    Denver, Colorado, 80218, United States

  • Research Site

    Sarasota, Florida, 34232, United States

  • Research Site

    Boston, Massachusetts, 02114, United States

  • Research Site

    Boston, Massachusetts, 02215, United States

  • Research Site

    St Louis, Missouri, 63110, United States

  • Research Site

    Nashville, Tennessee, 37203, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    San Antonio, Texas, 78229, United States

  • Research Site

    Fairfax, Virginia, 22031, United States

  • Research Site

    Madison, Wisconsin, 53792, United States

  • Research Site

    Randwick, New South Wales, 2031, Australia

  • Research Site

    Malvern, Victoria, 3144, Australia

  • Research Site

    Nedlands, Western Australia, 6009, Australia

  • Research Site

    Caen, 14000, France

  • Research Site

    Villejuif, 94800, France

  • Research Site

    Kyoto, 606-8507, Japan

  • Research Site

    Tokyo, 135-8550, Japan

  • Research Site

    Seoul, 06591, South Korea

  • Research Site

    Seoul, 13620, South Korea

  • Research Site

    Barcelona, 08035, Spain

  • Research Site

    Barcelona, 08908, Spain

  • Research Site

    Madrid, 28023, Spain

  • Research Site

    Madrid, 28040, Spain

  • Research Site

    Taipei, 100, Taiwan

  • Research Site

    London, SW3 6JJ, United Kingdom

  • Research Site

    London, W1G 6AD, United Kingdom

  • Research Site

    Manchester, M10 4BX, United Kingdom

  • Research Site

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Research Site

    Sutton, SM2 5PT, United Kingdom

  • Research Site #2

    San Antonio, Texas, 78229, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.