EICHORCondition: Advanced Solid Tumors · Breast Cancer · Breast Carcinoma · Sponsor: Atavistik Bio, Inc
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| USC Norris Comprehensive Cancer Center | Los Angeles, California, United States | — |
| Florida Cancer Specialists & Research Institute - Lake Mary | Lake Mary, Florida, United States | — |
| Massachusetts General Hospital | Boston, Massachusetts, United States | — |
| Washington University | St Louis, Missouri, United States | — |
| MD Anderson Cancer Center | Houston, Texas, United States | — |
| Centre Leon Berard | Lyon, France | — |
| National Cancer Centre Singapore | Singapore, Singapore | — |
| START Madrid - CIOCC | Madrid, Spain | — |
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Source record: clinicaltrials.gov/study/NCT07038369