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

Description

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

Conditions

Cancer, Breast Cancer, Endometrial Cancer, Metastatic Cancer, Advanced Solid Tumor

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Cancer
Intervention / Treatment

-

Contacts and Locations

Denver

Research Site, Denver, Colorado, United States, 80218

Sarasota

Research Site, Sarasota, Florida, United States, 34232

Boston

Research Site, Boston, Massachusetts, United States, 02114

Nashville

Research Site, Nashville, Tennessee, United States, 37203

Dallas

Research Site, Dallas, Texas, United States, 75251

Houston

Research Site, Houston, Texas, United States, 77030

San Antonio

Research Site, San Antonio, Texas, United States, 78229

Fairfax

Research Site, Fairfax, Virginia, United States, 22031

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alterome Therapeutics, Inc.,

Study Medical Director, STUDY_DIRECTOR, Alterome Therapeutics

Study Record Dates

2027-12-29