Clinical trial · Interventional
A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations
A Phase 1 Study of a Selective AKT1 E17K Allosteric Inhibitor, ATV-1601, in Patients With Advanced Solid Tumors
NCT07038369CI-TRIAL-00121014active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (27)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Breast Diseases | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Cervical Cancers | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cervical Neoplasms | Cervical Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Endometrial Carcinoma (EC) |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATV-1601 | Drug | — | UNRESOLVED |
| ATV-1601 + Fulvestrant | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental/Part 1a: ATV-1601
- description
- ATV-1601
- interventionNames
- Drug: ATV-1601
- type
- EXPERIMENTAL
- label
- Experimental/Part 1b: ATV-1601 + Fulvestrant
- description
- ATV-1601 + Fulvestrant
- interventionNames
- Combination Product: ATV-1601 + Fulvestrant
Primary outcomes (10)
- measure
- Expansion: Maximum and minimum plasma concentration
- timeFrame
- Approximately 48 months.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.