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

NCT07038369
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Active, not recruiting
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Participants
134
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Lead sponsor
Atavistik Bio, Inc
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Start date
2025-07-29
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Number of sites
8
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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.
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Short title
A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations
clinicaltrials.gov
Official title
A Phase 1 Study of a Selective AKT1 E17K Allosteric Inhibitor, ATV-1601, in Patients With Advanced Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2029-01-31
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First posted
2025-06-26
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Registry last updated
2026-08-07
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Primary completion date
2028-08-31
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Start date
2025-07-29
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Participants
134
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Participant count basis
Estimated
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Planned participants
134
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Protocol amendments
1
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Number of sites
8
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Registry sponsor category
Industry
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Lead sponsor
Atavistik Bio, Inc
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07038369
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ClinicalTrials.gov ID
NCT07038369
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Expansion: Maximum and minimum plasma concentration

    Timeframe: Approximately 48 months.

    Drug concentration in Blood.

  2. Expansion: Time to C Max

    Timeframe: Approximately 48 months

    Drug concentration in Blood

  3. Expansion: Area under the concentration-time curve

    Timeframe: Approximately 48 months

    Drug concentration in Blood

  4. Expansion: AUC at end of dosing interval

    Timeframe: Approximately 48 months

    Drug concentration in Blood

  5. Expansion: AUC extrapolated to infinity

    Timeframe: Approximately 48 months

    Drug concentration in Blood

  6. Expansion: Half-life

    Timeframe: Approximately 48 months

    Drug concentration in Blood

  7. Expansion: Trough Concentrations

    Timeframe: Approximately 48 months

    Drug concentration in Blood

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

    Timeframe: 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.

    Timeframe: 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.

    Timeframe: Approximately 48 months.

    Number of patients with dose-limiting toxicities.

  1. Escalation: Maximum and minimum plasma concentration

    Timeframe: Approximately 48 months.

    Drug concentration in Blood.

  2. Escalation: Time to C max

    Timeframe: Approximately 48 months

    Drug concentration in Blood

  3. Escalation: Area under the concentration-time curve

    Timeframe: Approximately 48 months

    Drug concentration in Blood

  4. Escalation: AUC at end of dosing interval

    Timeframe: Approximately 48 months

    Drug concentration in Blood

  5. Escalation: AUC extrapolated to infinity

    Timeframe: Approximately 48 months

    Drug concentration in Blood

  6. Escalation: Half-life

    Timeframe: Approximately 48 months

    Drug concentration in Blood

  7. Escalation: Trough Concentrations

    Timeframe: Approximately 48 months

    Drug concentration in Blood

  8. Escalation & Expansion: Objective response rate

    Timeframe: Approximately 48 months

    Tumor measurements by RECIST 1.1

  9. Escalation & Expansion: Duration of Response

    Timeframe: Approximately 48 months

    Tumor measurements by RECIST 1.1

  10. Escalation & Expansion: Clinical Benefit Rate

    Timeframe: Approximately 48 months

    Tumor measurements by RECIST 1.1

  11. Expansion: Progression Free Survival

    Timeframe: Approximately 48 months

    Tumor measurements by RECIST 1.1

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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.

Participants must meet other inclusion/exclusion criteria.

Sources for eligibility
clinicaltrials.gov

  • USC Norris Comprehensive Cancer CenterLos Angeles, United States
  • Florida Cancer Specialists & Research Institute - Lake MaryLake Mary, United States
  • Massachusetts General HospitalBoston, United States
  • Washington UniversitySt Louis, United States
  • MD Anderson Cancer CenterHouston, United States
  • Centre Leon BerardLyon, France
  • National Cancer Centre SingaporeSingapore, Singapore
  • START Madrid - CIOCCMadrid, Spain
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (19)

Targets (3)