RECRUITING

A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations

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Conditions

Advanced Solid TumorsBreast CancerBreast CarcinomaBreast NeoplasmsER Positive Breast CancerCervical CancersCervical NeoplasmsCervical CarcinomaTriple Negative Breast CancerGynecologic CancersGynecologic NeoplasmEndometrial CancerEndometrial NeoplasmEndometrial Carcinoma (EC)Fallopian CancerOvarian CarcinomaOvarian CancerOvarian NeoplasmsProstate CancersProstate CarcinomaSolid TumorsNeoplasmsNeoplasms by SiteBreast DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsAKT mutationMutant AKTAKT1 mutationAKT mutantGynecologic carcinomaFallopian CarcinomaFallopian NeoplasmHR positive breastAKT Gene MutationAKT1 E17K

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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

This is a Phase 1, open-label study to evaluate the safety and tolerability of ATV-1601 administered orally in adults with AKT1 E17K-mutant, advanced solid tumors and also in HR+/HER2- advanced and metastatic breast cancer, with or without fulvestrant.

Official Title

A Phase 1 Study of a Selective AKT1 E17K Allosteric Inhibitor, ATV-1601, in Patients With Advanced Solid Tumors

Quick Facts

Study Start:2025-07-29
Study Completion:2029-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07038369

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. 1. Histologically or cytologically confirmed metastatic or advanced-stage solid malignant tumor or HR+/HER2- breast cancer.
  2. 2. Have progressed on, were intolerant to, or experienced disease recurrence after standard therapy and have no available effective or tolerable treatment options to derive clinically meaningful benefit.
  3. 3. Tumor must have documented specific mutation profile as outlined below based on local laboratory testing.
  4. 4. Participants with solid tumors or HR+/HER2- breast cancer with AKT1 E17K mutations.
  5. 5. Measurable disease according to RECIST v1.1 criteria.
  6. 6. Formalin-fixed paraffin-embedded tumor specimen available for submission.
  7. 7. Eastern Cooperative Oncology Group performance status of 0 or 1.
  1. 1. Previously documented activating mutations in KRAS, NRAS, HRAS, or BRAF.
  2. 2. Inadequate bone marrow reserve or organ function.
  3. 3. Clinically significant abnormalities of glucose metabolism.
  4. 4. Participants who are symptomatic or have uncontrolled brain metastases.
  5. 5. Requires treatment with certain medications.

Contacts and Locations

Study Contact

Study Director
CONTACT
+1- 857-285-5400
Studydirector@atavistikbio.com

Principal Investigator

Study Director
STUDY_DIRECTOR
Atavistik Bio

Study Locations (Sites)

Study Center
Lake Mary, Florida, 32746
United States
Study Center
Boston, Massachusetts, 02114
United States
Study Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Atavistik Bio, Inc

  • Study Director, STUDY_DIRECTOR, Atavistik Bio

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 Date2025-07-29
Study Completion Date2029-01-31

Study Record Updates

Study Start Date2025-07-29
Study Completion Date2029-01-31

Terms related to this study

Keywords Provided by Researchers

  • AKT mutation
  • Mutant AKT
  • AKT1 mutation
  • AKT mutant
  • Gynecologic carcinoma
  • Fallopian Carcinoma
  • Fallopian Neoplasm
  • HR positive breast
  • AKT Gene Mutation
  • AKT1 E17K

Additional Relevant MeSH Terms

  • Advanced Solid Tumors
  • Breast Cancer
  • Breast Carcinoma
  • Breast Neoplasms
  • ER Positive Breast Cancer
  • Cervical Cancers
  • Cervical Neoplasms
  • Cervical Carcinoma
  • Triple Negative Breast Cancer
  • Gynecologic Cancers
  • Gynecologic Neoplasm
  • Endometrial Cancer
  • Endometrial Neoplasm
  • Endometrial Carcinoma (EC)
  • Fallopian Cancer
  • Ovarian Carcinoma
  • Ovarian Cancer
  • Ovarian Neoplasms
  • Prostate Cancers
  • Prostate Carcinoma
  • Solid Tumors
  • Neoplasms
  • Neoplasms by Site
  • Breast Diseases
  • Uterine Neoplasms
  • Genital Neoplasms, Female
  • Urogenital Neoplasms