RecruitingPhase 1NCT06533059

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

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

Sponsor

Alterome Therapeutics, Inc.

Enrollment

110 participants

Start Date

Aug 22, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Endometrial Cancer Advanced Solid Tumor Cancer Metastatic Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called ALTA2618 in adults with solid tumors (cancers in organs like breast, lung, colon, etc.) that carry a specific genetic change called AKT1 E17K mutation. This mutation makes a protein that promotes cancer growth overly active. ALTA2618 is designed to block this protein. The study is for patients whose cancer has already been treated with standard options but has continued to grow or spread. **You may be eligible if...** - You have a confirmed solid tumor with the AKT1 E17K mutation found on a standard genetic test - Your cancer cannot be removed by surgery or has spread to other parts of the body - You have already been treated with standard therapies appropriate for your cancer type, or they are not available - You are in reasonably good health (ECOG 0 or 1) - Your organ function is adequate **You may NOT be eligible if...** - You have previously been treated with PI3K or mTOR inhibitors (a related class of drugs) - Your tumor also has certain other mutations like KRAS, NRAS, HRAS, or BRAF - You have a condition that prevents you from swallowing or absorbing an oral medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGALTA2618

Oral ALTA2618 tablets will be administered at protocol-defined dose

Locations(51)

Research Site

La Jolla, California, United States

Research Site

Los Angeles, California, United States

Research Site

Denver, Colorado, United States

Research Site

Sarasota, Florida, United States

Research Site

Atlanta, Georgia, United States

Research Site

Boston, Massachusetts, United States

Research Site

Boston, Massachusetts, United States

Research Site

St Louis, Missouri, United States

Research Site

Mineola, New York, United States

Research Site

New York, New York, United States

Research Site

Maumee, Ohio, United States

Research Site

Nashville, Tennessee, United States

Research Site

Dallas, Texas, United States

Research Site

Houston, Texas, United States

Research Site #2

San Antonio, Texas, United States

Research Site

San Antonio, Texas, United States

Research Site

Fairfax, Virginia, United States

Research Site

Madison, Wisconsin, United States

Research Site

Blacktown, New South Wales, Australia

Research Site

Randwick, New South Wales, Australia

Research Site

South Brisbane, Queensland, Australia

Research Site

Malvern, Victoria, Australia

Research Site

Nedlands, Western Australia, Australia

Research Site

Caen, France

Research Site

Dijon, France

Research Site

Saint-Herblain, France

Research Site

Villejuif, France

Research Site

Kyoto, Japan

Research Site

Matsuyama, Japan

Research Site

Shizuoka, Japan

Research Site

Tokyo, Japan

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Barcelona, Spain

Research Site

Barcelona, Spain

Research Site

Barcelona, Spain

Research Site

Madrid, Spain

Research Site

Madrid, Spain

Research Site

Valencia, Spain

Research Site

Changhua, Taiwan

Research Site

Taipei, Taiwan

Research Site

Taipei, Taiwan

Research Site

London, United Kingdom

Research Site

London, United Kingdom

Research Site

London, United Kingdom

Research Site

Manchester, United Kingdom

Research Site

Newcastle upon Tyne, United Kingdom

Research Site

Sutton, United Kingdom

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