NCT07038369

Brief Summary

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P75+ for phase_1

Timeline
34mo left

Started Jul 2025

Typical duration for phase_1

Geographic Reach
4 countries

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Jul 2025Jan 2029

First Submitted

Initial submission to the registry

June 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 26, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 29, 2025

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3.1 years

First QC Date

June 18, 2025

Last Update Submit

March 16, 2026

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

Keywords

AKT mutationMutant AKTAKT1 mutationAKT mutantGynecologic carcinomaFallopian CarcinomaFallopian NeoplasmHR positive breastAKT Gene MutationAKT1 E17K

Outcome Measures

Primary Outcomes (10)

  • Expansion: Maximum and minimum plasma concentration

    Drug concentration in Blood.

    Approximately 48 months.

  • Expansion: Time to C Max

    Drug concentration in Blood

    Approximately 48 months

  • Expansion: Area under the concentration-time curve

    Drug concentration in Blood

    Approximately 48 months

  • Expansion: AUC at end of dosing interval

    Drug concentration in Blood

    Approximately 48 months

  • Expansion: AUC extrapolated to infinity

    Drug concentration in Blood

    Approximately 48 months

  • Expansion: Half-life

    Drug concentration in Blood

    Approximately 48 months

  • Expansion: Trough Concentrations

    Drug concentration in Blood

    Approximately 48 months

  • Escalation & Expansion: Safety and Tolerability of monotherapy.

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

    Approximately 48 months.

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

    Number of patients with dose-limiting toxicities.

    Approximately 48 months.

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

    Number of patients with dose-limiting toxicities.

    Approximately 48 months.

Secondary Outcomes (11)

  • Escalation: Maximum and minimum plasma concentration

    Approximately 48 months.

  • Escalation: Time to C max

    Approximately 48 months

  • Escalation: Area under the concentration-time curve

    Approximately 48 months

  • Escalation: AUC at end of dosing interval

    Approximately 48 months

  • Escalation: AUC extrapolated to infinity

    Approximately 48 months

  • +6 more secondary outcomes

Study Arms (2)

Experimental/Part 1a: ATV-1601

EXPERIMENTAL

ATV-1601

Drug: ATV-1601

Experimental/Part 1b: ATV-1601 + Fulvestrant

EXPERIMENTAL

ATV-1601 + Fulvestrant

Combination Product: ATV-1601 + Fulvestrant

Interventions

ATV-1601DRUG

Drug: ATV-1601 • Oral ATV-1601

Experimental/Part 1a: ATV-1601
ATV-1601 + FulvestrantCOMBINATION_PRODUCT

Drug: ATV-1601 * Oral ATV-1601 Drug: Fulvestrant * Intramuscular Injection

Experimental/Part 1b: ATV-1601 + Fulvestrant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Florida Cancer Specialists & Research Institute - Lake Mary

Lake Mary, Florida, 32746, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Centre Leon Berard

Lyon, 69008, France

Location

National Cancer Centre Singapore

Singapore, 168583, Singapore

Location

START Madrid - CIOCC

Madrid, 28050, Spain

Location

MeSH Terms

Conditions

Breast NeoplasmsUterine Cervical NeoplasmsTriple Negative Breast NeoplasmsGenital Neoplasms, FemaleEndometrial NeoplasmsOvarian NeoplasmsProstatic NeoplasmsNeoplasmsNeoplasms by SiteBreast DiseasesUterine NeoplasmsUrogenital Neoplasms

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Study Director

    Atavistik Bio

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2025

First Posted

June 26, 2025

Study Start

July 29, 2025

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

January 31, 2029

Last Updated

March 17, 2026

Record last verified: 2026-03

Locations

US(5)SG(1)FR(1)ES(1)