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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Primary outcome measure(s)
Expansion: Maximum and minimum plasma concentration — Approximately 48 months. Drug concentration in Blood.
Expansion: Time to C Max — Approximately 48 months Drug concentration in Blood
Expansion: Area under the concentration-time curve — Approximately 48 months Drug concentration in Blood
Expansion: AUC at end of dosing interval — Approximately 48 months Drug concentration in Blood
Expansion: AUC extrapolated to infinity — Approximately 48 months Drug concentration in Blood
Expansion: Half-life — Approximately 48 months Drug concentration in Blood
Expansion: Trough Concentrations — Approximately 48 months Drug concentration in Blood
Escalation & Expansion: Safety and Tolerability of monotherapy. — 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.
Escalation: Maximum tolerated dose and/or recommended phase 2 dose of ATV-1601 in monotherapy. — Approximately 48 months. Number of patients with dose-limiting toxicities.
Escalation: Maximum tolerated dose and/or recommended phase 2 dose of ATV-1601 combination with fulvestrant. — Approximately 48 months. Number of patients with dose-limiting toxicities.
Trial sites (8)
Facility
City
Region
Status
USC Norris Comprehensive Cancer Center
Los Angeles
California
Florida Cancer Specialists & Research Institute - Lake Mary
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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