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

Study Identifier:
ATV-1601-101
CT.gov Identifier:
NCT07038369
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
2025-521480-12-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

Considering participating in a START clinical trial?

Get Started

Study Summary

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.

To evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of ATV-1601 as monotherapy in participants with advanced or metastatic AKT1 E17K-mutant solid tumors, and in combination with fulvestrant in participants with AKT1 E17K-mutant HR-positive/HER2-negative breast cancer. The Phase 1 study has a dose escalation and expansion phase with AKT-1601 monotherapy, and an escalation and expansion phase with AKT-1601 in combination with fulvestrant

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
  • Breast Cancers
  • Breast
  • Cervical cancer
  • Uterine
  • Other
  • Endometrial
  • Fallopian Tube
  • Ovarian
  • Prostate
  • Neoplasms
  • Urogenital
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Experimental/Part 1a
    • Read More
  • Drug: Experimental: Experimental/Part 1b
  • Drug: Combination Product: ATV-1601 + Fulvestrant
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

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

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Juan José Soto
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor
    Breast Cancers
    Breast
    Cervical cancer
    Uterine
    Other
    Endometrial
    Fallopian Tube
    Ovarian
    Prostate
    Neoplasms
    Urogenital
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor
    Breast Cancers
    Breast
    Cervical cancer
    Uterine
    Other
    Endometrial
    Fallopian Tube
    Ovarian
    Prostate
    Neoplasms
    Urogenital