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

May 21, 2026 updated by: Alterome Therapeutics, Inc.

AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients With Advanced Solid Tumors With AKT1 E17K Mutation

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Research Site
      • Randwick, New South Wales, Australia, 2031
        • Research Site
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Research Site
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • Research Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Research Site
  • France
      • Caen, France, 14000
        • Research Site
      • Dijon, France, 21000
        • Research Site
      • Saint-Herblain, France, 44805
        • Research Site
      • Villejuif, France, 94800
        • Research Site
  • Japan
      • Kyoto, Japan, 606-8507
        • Research Site
      • Matsuyama, Japan, 791-0280
        • Research Site
      • Shizuoka, Japan, 411-8777
        • Research Site
      • Tokyo, Japan, 135-8550
        • Research Site
  • South Korea
      • Seoul, South Korea, 03722
        • Research Site
      • Seoul, South Korea, 05505
        • Research Site
      • Seoul, South Korea, 06591
        • Research Site
      • Seoul, South Korea, 13620
        • Research Site
  • Spain
      • Barcelona, Spain, 08035
        • Research Site
      • Barcelona, Spain, 08023
        • Research Site
      • Barcelona, Spain, 08908
        • Research Site
      • Madrid, Spain, 28040
        • Research Site
      • Madrid, Spain, 28023
        • Research Site
      • Valencia, Spain, 46010
        • Research Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Research Site
      • Taipei, Taiwan, 100
        • Research Site
      • Taipei, Taiwan, 10449
        • Research Site
  • United Kingdom
      • London, United Kingdom, W1G 6AD
        • Research Site
      • London, United Kingdom, SW3 6JJ
        • Research Site
      • London, United Kingdom, W1T 7HA
        • Research Site
      • Manchester, United Kingdom, M10 4BX
        • Research Site
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Research Site
      • Sutton, United Kingdom, SM2 5PT
        • Research Site
  • United States
    • California
      • La Jolla, California, United States, 92093
        • Research Site
    • Colorado
      • Denver, Colorado, United States, 80218
        • Research Site
    • Florida
      • Sarasota, Florida, United States, 34232
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Research Site
      • Boston, Massachusetts, United States, 02215
        • Research Site
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Research Site
    • Ohio
      • Maumee, Ohio, United States, 43637
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site #2
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALTA2618
ALTA2618 will be administered continuously at a protocol-defined dose based on cohort assignment
Drug: ALTA2618
Oral ALTA2618 tablets will be administered at protocol-defined dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Up to 39 months
Number of participants that experience treatment-emergent adverse events (TEAEs).
Up to 39 months
Dose Limiting Toxicities
Time Frame: 21 days
Number of participants with Dose Limiting Toxicities (DLTs).
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
Cmax
Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
Tmax
Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt)
Time Frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
AUCt
Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
Terminal Half-Life (t1/2)
Time Frame: Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 72 hours postdose
t1/2
Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 72 hours postdose
Overall Response Rate (ORR)
Time Frame: Up to 39 months
Assess per RECIST 1.1
Up to 39 months
Duration of Response (DOR)
Time Frame: Up to 39 months
Assess per RECIST 1.1
Up to 39 months
Progression-Free Survival (PFS)
Time Frame: Up to 39 months
Assess per RECIST 1.1
Up to 39 months
Overall Survival (OS)
Time Frame: Up to 39 months
Assess per RECIST 1.1
Up to 39 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alterome Therapeutics, Inc.

Investigators

  • Study Director: Study Medical Director, Alterome Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2024

Primary Completion (Estimated)

December 29, 2026

Study Completion (Estimated)

December 29, 2027

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2618-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe