Active — Not RecruitingPhase 1

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

United States134 participantsStarted 2025-07-29

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Expansion: Maximum and minimum plasma concentration

Timeframe: Approximately 48 months.

Expansion: Time to C Max

Timeframe: Approximately 48 months

Expansion: Area under the concentration-time curve

Timeframe: Approximately 48 months

Expansion: AUC at end of dosing interval

Timeframe: Approximately 48 months

Expansion: AUC extrapolated to infinity

Timeframe: Approximately 48 months

Expansion: Half-life

Timeframe: Approximately 48 months

Expansion: Trough Concentrations

Timeframe: Approximately 48 months

Escalation & Expansion: Safety and Tolerability of monotherapy.

Timeframe: Approximately 48 months.

Trial details

NCT IDNCT07038369

SponsorAtavistik Bio, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-08-31

View on ClinicalTrials.gov More Advanced Solid Tumors trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Expansion: Maximum and minimum plasma concentration

Timeframe: Approximately 48 months.

Expansion: Time to C Max

Timeframe: Approximately 48 months

Expansion: Area under the concentration-time curve

Timeframe: Approximately 48 months

Expansion: AUC at end of dosing interval

Timeframe: Approximately 48 months

Expansion: AUC extrapolated to infinity

Timeframe: Approximately 48 months

Expansion: Half-life

Timeframe: Approximately 48 months

Expansion: Trough Concentrations

Timeframe: Approximately 48 months

Escalation & Expansion: Safety and Tolerability of monotherapy.

Timeframe: Approximately 48 months.