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Active, Not Recruiting

NCT Number: NCT07038369

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Advanced Solid Tumors Adnexal Diseases Breast Cancer Breast Carcinoma Breast Diseases Breast Neoplasms CERVICAL NEOPLASMS Cervical Cancers Cervical Carcinoma ER Positive Breast Cancer Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Carcinoma (EC) Endometrial Neoplasm Endometrial Neoplasms Fallopian Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Gynecologic Cancers Gynecologic Neoplasm Male Urogenital Diseases Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Carcinoma Ovarian Diseases Ovarian Neoplasms Prostate Cancers Prostate Carcinoma Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Solid Tumors Triple Negative Breast Cancer Triple Negative Breast Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre Leon Berard, Lyon, France

Loading trial locations.

About this study

This is a first-in-human, open-label, multicenter, Phase 1a/1b dose escalation dose finding, and dose expansion study to evaluate safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of ATV-1601 as monotherapy in participants with advanced or metastatic solid tumors with the AKT1 E17K mutation, and in combination with fulvestrant in participants with breast cancer that has the AKT1 E17K mutation. This study has a dose escalation and expansion phase with ATV-1601, and an escalation and expansion phase in combination with Fulvestrant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ATV-1601

Drug

Drug: ATV-1601

  • Oral ATV-1601

ATV-1601 + Fulvestrant

Combination Product

Drug: ATV-1601

  • Oral ATV-1601 Drug: Fulvestrant
  • Intramuscular Injection

Primary outcomes

  1. Expansion: Maximum and minimum plasma concentration

    Time frame: Approximately 48 months.

    Drug concentration in Blood.

  2. Expansion: Time to C Max

    Time frame: Approximately 48 months

    Drug concentration in Blood

  3. Expansion: Area under the concentration-time curve

    Time frame: Approximately 48 months

    Drug concentration in Blood

  4. Expansion: AUC at end of dosing interval

    Time frame: Approximately 48 months

    Drug concentration in Blood

  5. Expansion: AUC extrapolated to infinity

    Time frame: Approximately 48 months

    Drug concentration in Blood

  6. Expansion: Half-life

    Time frame: Approximately 48 months

    Drug concentration in Blood

  7. Expansion: Trough Concentrations

    Time frame: Approximately 48 months

    Drug concentration in Blood

  8. Escalation & Expansion: Safety and Tolerability of monotherapy.

    Time frame: Approximately 48 months.

    Number of participants with Treatment Emergent Adverse Events (TEAEs). Safety will be assessed by monitoring adverse events, laboratory tests and ECG results.

  9. Escalation: Maximum tolerated dose and/or recommended phase 2 dose of ATV-1601 in monotherapy.

    Time frame: Approximately 48 months.

    Number of patients with dose-limiting toxicities.

  10. Escalation: Maximum tolerated dose and/or recommended phase 2 dose of ATV-1601 combination with fulvestrant.

    Time frame: Approximately 48 months.

    Number of patients with dose-limiting toxicities.

Secondary outcomes

  1. Escalation: Maximum and minimum plasma concentration

    Time frame: Approximately 48 months.

    Drug concentration in Blood.

  2. Escalation: Time to C max

    Time frame: Approximately 48 months

    Drug concentration in Blood

  3. Escalation: Area under the concentration-time curve

    Time frame: Approximately 48 months

    Drug concentration in Blood

  4. Escalation: AUC at end of dosing interval

    Time frame: Approximately 48 months

    Drug concentration in Blood

  5. Escalation: AUC extrapolated to infinity

    Time frame: Approximately 48 months

    Drug concentration in Blood

  6. Escalation: Half-life

    Time frame: Approximately 48 months

    Drug concentration in Blood

  7. Escalation: Trough Concentrations

    Time frame: Approximately 48 months

    Drug concentration in Blood

  8. Escalation & Expansion: Objective response rate

    Time frame: Approximately 48 months

    Tumor measurements by RECIST 1.1

  9. Escalation & Expansion: Duration of Response

    Time frame: Approximately 48 months

    Tumor measurements by RECIST 1.1

  10. Escalation & Expansion: Clinical Benefit Rate

    Time frame: Approximately 48 months

    Tumor measurements by RECIST 1.1

  11. Expansion: Progression Free Survival

    Time frame: Approximately 48 months

    Tumor measurements by RECIST 1.1

Sponsors and collaborators

Lead sponsor

Atavistik Bio, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jun 26, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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