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

> **NCT07038369** · PHASE1 · ACTIVE_NOT_RECRUITING · sponsor: **Atavistik Bio, Inc** · enrollment: 134 (estimated)

## Conditions studied

- 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 Neoplasms

## Interventions

- **DRUG:** ATV-1601
- **COMBINATION_PRODUCT:** ATV-1601 + Fulvestrant

## Key facts

- **NCT ID:** NCT07038369
- **Lead sponsor:** Atavistik Bio, Inc
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2025-07-29
- **Primary completion:** 2028-08-31
- **Final completion:** 2029-01-31
- **Target enrollment:** 134 (ESTIMATED)
- **Last updated:** 2026-03-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07038369

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07038369, "A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT07038369. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
