A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations
Status
RECRUITING
Phase
PHASE1
Age
≥ 18 Years
Enrollments
134Conditions
Advanced Solid Tumors, Breast Cancer, Breast Carcinoma, Breast Neoplasms, ER Positive Breast Cancer, Cervical Cancers, Cervical Neoplasms, Cervical Carcinoma, Triple Negative Breast Cancer, Gynecologic Cancers, Gynecologic Neoplasm, Endometrial Cancer, Endometrial Neoplasm, Endometrial Carcinoma (EC), Fallopian Cancer, Ovarian Carcinoma, Ovarian Cancer, Ovarian Neoplasms, Prostate Cancers, Prostate Carcinoma, Solid Tumors, Neoplasms, Neoplasms by Site, Breast Diseases, Uterine Neoplasms, Genital Neoplasms, Female, Urogenital NeoplasmsDrugs
ATV-1601Summary
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.
Detailed Description
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.
Locations
8 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Study Director
- 857-285-5400
- [email protected]
Study Director
- Study Director
Status
- RECRUITING
Contact Person
- Study Director
- 857-285-5400
- [email protected]
Study Director
- Study Director
Status
- RECRUITING
Contact Person
- Study Director
- 857-285-5400
- [email protected]
Study Director
- Study Director
Status
- RECRUITING
Contact Person
- Study Director
- 857-285-5400
- [email protected]
Study Director
- Study Director
Status
- RECRUITING
Contact Person
- Study Director
- 857-285-5400
- [email protected]
Study Director
- Study Director
Status
- RECRUITING
Contact Person
- Study Director
- 857-285-5400
- [email protected]
Study Director
- Study Director
Status
- RECRUITING
Contact Person
- Study Director
- 857-285-5400
- [email protected]
Study Director
- Study Director
Status
- RECRUITING
Contact Person
- Study Director
- 857-285-5400
- [email protected]
Study Director
- Study Director
Eligibility Criteria
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.
Study Plan
Experimental/Part 1a: ATV-1601
EXPERIMENTAL
ATV-1601
DRUG:
ATV-1601Description:
Drug: ATV-1601nnu2022 Oral ATV-1601
Experimental/Part 1b: ATV-1601 + Fulvestrant
EXPERIMENTAL
ATV-1601 + Fulvestrant
COMBINATION_PRODUCT:
ATV-1601 + FulvestrantDescription:
Drug: ATV-1601nn* Oral ATV-1601 Drug: Fulvestrantn* Intramuscular Injection
Outcome Measures
Primary Outcome Measures
Expansion: Maximum and minimum plasma concentration
Expansion: Time to C Max
Expansion: Area under the concentration-time curve
Expansion: AUC at end of dosing interval
Expansion: AUC extrapolated to infinity
Expansion: Half-life
Expansion: Trough Concentrations
Escalation & Expansion: Safety and Tolerability of monotherapy.
Escalation: Maximum tolerated dose and/or recommended phase 2 dose of ATV-1601 in monotherapy.
Escalation: Maximum tolerated dose and/or recommended phase 2 dose of ATV-1601 combination with fulvestrant.
Secondary Outcome Measures
Escalation: Maximum and minimum plasma concentration
Escalation: Time to C max
Escalation: Area under the concentration-time curve
Escalation: AUC at end of dosing interval
Escalation: AUC extrapolated to infinity
Escalation: Half-life
Escalation: Trough Concentrations
Escalation & Expansion: Objective response rate
Escalation & Expansion: Duration of Response
Escalation & Expansion: Clinical Benefit Rate
Expansion: Progression Free Survival
Timeline
Last Updated
December 9, 2025Start Date
June 26, 2025Today
December 19, 2025Completion Date ( Estimated )
January 31, 2029
Sponsors of this trial
Lead Sponsor
Atavistik Bio, Inc
RECRUITING 
18 - 80 Years