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

NCT ID: NCT06533059

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-22

Study Completion Date

2027-12-29

Brief Summary

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

Detailed Description

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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.

Conditions

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Cancer Breast Cancer Endometrial Cancer Metastatic Cancer Advanced Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ALTA2618

ALTA2618 will be administered continuously at a protocol-defined dose based on cohort assignment

Group Type EXPERIMENTAL

ALTA2618

Intervention Type DRUG

Oral ALTA2618 tablets will be administered at protocol-defined dose

Interventions

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ALTA2618

Oral ALTA2618 tablets will be administered at protocol-defined dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alterome Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Medical Director

Role: STUDY_DIRECTOR

Alterome Therapeutics

Locations

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Research Site

La Jolla, California, United States

Site Status RECRUITING

Research Site

Los Angeles, California, United States

Site Status RECRUITING

Research Site

Denver, Colorado, United States

Site Status RECRUITING

Research Site

Sarasota, Florida, United States

Site Status RECRUITING

Research Site

Atlanta, Georgia, United States

Site Status RECRUITING

Research Site

Boston, Massachusetts, United States

Site Status RECRUITING

Research Site

Boston, Massachusetts, United States

Site Status RECRUITING

Research Site

St Louis, Missouri, United States

Site Status RECRUITING

Research Site

Mineola, New York, United States

Site Status RECRUITING

Research Site

New York, New York, United States

Site Status RECRUITING

Research Site

Maumee, Ohio, United States

Site Status RECRUITING

Research Site

Nashville, Tennessee, United States

Site Status RECRUITING

Research Site

Dallas, Texas, United States

Site Status WITHDRAWN

Research Site

Houston, Texas, United States

Site Status RECRUITING

Research Site #2

San Antonio, Texas, United States

Site Status RECRUITING

Research Site

San Antonio, Texas, United States

Site Status RECRUITING

Research Site

Fairfax, Virginia, United States

Site Status RECRUITING

Research Site

Madison, Wisconsin, United States

Site Status RECRUITING

Research Site

Blacktown, New South Wales, Australia

Site Status RECRUITING

Research Site

Randwick, New South Wales, Australia

Site Status RECRUITING

Research Site

South Brisbane, Queensland, Australia

Site Status RECRUITING

Research Site

Malvern, Victoria, Australia

Site Status RECRUITING

Research Site

Nedlands, Western Australia, Australia

Site Status RECRUITING

Research Site

Caen, , France

Site Status RECRUITING

Research Site

Dijon, , France

Site Status RECRUITING

Research Site

Saint-Herblain, , France

Site Status RECRUITING

Research Site

Villejuif, , France

Site Status RECRUITING

Research Site

Kyoto, , Japan

Site Status RECRUITING

Research Site

Matsuyama, , Japan

Site Status RECRUITING

Research Site

Shizuoka, , Japan

Site Status RECRUITING

Research Site

Tokyo, , Japan

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Barcelona, , Spain

Site Status RECRUITING

Research Site

Barcelona, , Spain

Site Status RECRUITING

Research Site

Barcelona, , Spain

Site Status RECRUITING

Research Site

Madrid, , Spain

Site Status RECRUITING

Research Site

Madrid, , Spain

Site Status RECRUITING

Research Site

Valencia, , Spain

Site Status RECRUITING

Research Site

Changhua, , Taiwan

Site Status RECRUITING

Research Site

Taipei, , Taiwan

Site Status RECRUITING

Research Site

Taipei, , Taiwan

Site Status RECRUITING

Research Site

London, , United Kingdom

Site Status RECRUITING

Research Site

London, , United Kingdom

Site Status RECRUITING

Research Site

London, , United Kingdom

Site Status RECRUITING

Research Site

Manchester, , United Kingdom

Site Status RECRUITING

Research Site

Newcastle upon Tyne, , United Kingdom

Site Status RECRUITING

Research Site

Sutton, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia France Japan South Korea Spain Taiwan United Kingdom

Central Contacts

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Alterome Clinical Trial Contact Center

Role: CONTACT

619-768-8189

Other Identifiers

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2618-001

Identifier Type: -

Identifier Source: org_study_id

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