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

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.

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 Neoplasms
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Related 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 Neoplasms

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Advanced Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Lake Mary

Study Center, Lake Mary, Florida, United States, 32746

Boston

Study Center, Boston, Massachusetts, United States, 02114

Houston

Study Center, Houston, Texas, United States, 77030

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

  • 1. Histologically or cytologically confirmed metastatic or advanced-stage solid malignant tumor or HR+/HER2- breast cancer.
  • 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. Tumor must have documented specific mutation profile as outlined below based on local laboratory testing.
  • 4. Participants with solid tumors or HR+/HER2- breast cancer with AKT1 E17K mutations.
  • 5. Measurable disease according to RECIST v1.1 criteria.
  • 6. Formalin-fixed paraffin-embedded tumor specimen available for submission.
  • 7. Eastern Cooperative Oncology Group performance status of 0 or 1.
  • 1. Previously documented activating mutations in KRAS, NRAS, HRAS, or BRAF.
  • 2. Inadequate bone marrow reserve or organ function.
  • 3. Clinically significant abnormalities of glucose metabolism.
  • 4. Participants who are symptomatic or have uncontrolled brain metastases.
  • 5. Requires treatment with certain medications.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Atavistik Bio, Inc,

Study Director, STUDY_DIRECTOR, Atavistik Bio

Study Record Dates

2029-01-31