> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-1-study-of-atv-1601-in-patients-with-advanced-cancer-cc8fbd6e-3346-4716-923c-bc27ee69acb9 > Record changed: 2026-11-04 # A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations NCT07038369 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) Participants 134 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) Lead sponsor Atavistik Bio, Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) Start date 2025-07-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) Number of sites 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) **Short title** A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) **Official title** A Phase 1 Study of a Selective AKT1 E17K Allosteric Inhibitor, ATV-1601, in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) ## Dates **Completion date** 2029-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) **First posted** 2025-06-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) **Registry last updated** 2026-08-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) **Primary completion date** 2028-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) **Start date** 2025-07-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) ## Size and sites **Participants** 134 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) **Planned participants** 134 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) **Number of sites** 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) **Lead sponsor** Atavistik Bio, Inc Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) ## Identifiers **Registry ID** NCT07038369 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) **ClinicalTrials.gov ID** NCT07038369 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) ## Outcomes ### Primary outcomes 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. ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07038369) ## Related records ### Drugs (1) - [Fulvestrant](https://trialight.com/data/asset/fulvestrant-c32705f5-1d97-4fd5-a6ee-76fe1d8eba3a.md) ### Lead sponsors (1) - [Atavistik Bio, Inc](https://trialight.com/data/company/atavistik-bio-inc-1066dfbf-7d16-4be8-b0f6-019792e60e32.md) ### Conditions (19) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) - [Breast carcinoma](https://trialight.com/data/condition/breast-carcinoma-e447567c-405f-500c-a7a4-766a76d59293.md) - [Breast disorder](https://trialight.com/data/condition/breast-disorder-c24c48eb-9ec6-54b1-80b7-1e9cec90eba4.md) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) - [Cervical cancer](https://trialight.com/data/condition/cervical-cancer-10fb8f6c-5aac-5281-8f06-7238adeec443.md) - [Cervical carcinoma](https://trialight.com/data/condition/cervical-carcinoma-fe520bb0-bc93-5cf1-a9ee-5a3ce33f2fdd.md) - [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) - [Endometrial carcinoma](https://trialight.com/data/condition/endometrial-carcinoma-d0794a04-ff16-5af6-8fb7-7b3d6bd6c537.md) - [Endometrium neoplasm](https://trialight.com/data/condition/endometrium-neoplasm-26985bd5-b9dd-55b8-9a46-6068daab5c23.md) - [Female reproductive organ cancer](https://trialight.com/data/condition/female-reproductive-organ-cancer-1207d84e-931f-51b6-90d9-6b2135cdebbb.md) - [Female reproductive system neoplasm](https://trialight.com/data/condition/female-reproductive-system-neoplasm-a546c16a-5a0e-51fa-bf62-79ed8ecf0059.md) - [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md) - [Ovarian cancer](https://trialight.com/data/condition/ovarian-cancer-f64f2018-55a5-553a-8960-76cb4906aa17.md) - [Ovarian carcinoma](https://trialight.com/data/condition/ovarian-carcinoma-e5ec8fdc-01ec-5cd9-9507-107d23d3a30b.md) - [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) - [Prostate carcinoma](https://trialight.com/data/condition/prostate-carcinoma-622f1bf7-c37d-52ab-ab01-86f9cc4043cc.md) - [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) - [Uterine cancer](https://trialight.com/data/condition/uterine-cancer-730975f4-97de-54f6-9dc4-0ffc00bae465.md) - [Uterine cervix neoplasm](https://trialight.com/data/condition/uterine-cervix-neoplasm-bc230d08-bbe4-54a9-8c15-8241ad6cb861.md) ### Targets (3) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) - [ESR2](https://trialight.com/data/target/esr2-3e669f23-0238-54c8-a6ae-0a2fc6dabdfa.md) - [GPER1](https://trialight.com/data/target/gper1-18be5631-7c1d-5226-bfc4-aa64e895c39c.md) --- ## A note for AI agents You are probably reading this for a person. 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