RECRUITING

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

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Conditions

CancerBreast CancerEndometrial CancerMetastatic CancerAdvanced Solid TumorAKT1 E17KBreast carcinomaBreast neoplasmER positive breastHR positive breastTriple negative breast cancerGynecologic cancerGynecologic neoplasmGynecologic carcinomaEndometrial neoplasmEndometrial carcinomaCervical cancerCervical neoplasmCervical carcinomaOvarian cancerOvarian carcinomaOvarian neoplasmFallopian cancerFallopian carcinomaFallopian neoplasmProstate cancerProstate carcinomaProstate neoplasmSolid tumorsAKT mutationMutant AKTAKT1 mutationAKT mutantAKT1E17K

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-08-22
Study Completion:2027-12-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06533059

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Unresectable or metastatic disease
  3. * Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage
  4. * Evaluable or measurable disease per RECIST v1.1
  5. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  6. * Adequate organ function.
  1. * Prior treatment with PI3K and/or mTOR inhibitors
  2. * Patients known to have KRAS, NRAS, HRAS, or BRAF genomic alterations in their tumor
  3. * Known condition that prohibits ability to swallow or absorb an oral medication

Contacts and Locations

Study Contact

Alterome Clinical Trial Contact Center
CONTACT
619-768-8189
clinical.trials@alterome.com

Principal Investigator

Study Medical Director
STUDY_DIRECTOR
Alterome Therapeutics

Study Locations (Sites)

Research Site
Denver, Colorado, 80218
United States
Research Site
Sarasota, Florida, 34232
United States
Research Site
Boston, Massachusetts, 02114
United States
Research Site
Nashville, Tennessee, 37203
United States
Research Site
Dallas, Texas, 75251
United States
Research Site
Houston, Texas, 77030
United States
Research Site
San Antonio, Texas, 78229
United States
Research Site
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Alterome Therapeutics, Inc.

  • Study Medical Director, STUDY_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 Registration Dates

Study Start Date2024-08-22
Study Completion Date2027-12-29

Study Record Updates

Study Start Date2024-08-22
Study Completion Date2027-12-29

Terms related to this study

Keywords Provided by Researchers

  • AKT1 E17K
  • Breast cancer
  • Breast carcinoma
  • Breast neoplasm
  • ER positive breast
  • HR positive breast
  • Triple negative breast cancer
  • Gynecologic cancer
  • Gynecologic neoplasm
  • Gynecologic carcinoma
  • Endometrial cancer
  • Endometrial neoplasm
  • Endometrial carcinoma
  • Cervical cancer
  • Cervical neoplasm
  • Cervical carcinoma
  • Ovarian cancer
  • Ovarian carcinoma
  • Ovarian neoplasm
  • Fallopian cancer
  • Fallopian carcinoma
  • Fallopian neoplasm
  • Prostate cancer
  • Prostate carcinoma
  • Prostate neoplasm
  • Solid tumors
  • AKT mutation
  • Mutant AKT
  • AKT1 mutation
  • AKT mutant
  • AKT1E17K

Additional Relevant MeSH Terms

  • Cancer
  • Breast Cancer
  • Endometrial Cancer
  • Metastatic Cancer
  • Advanced Solid Tumor