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A Phase 1 Study of a Selective AKT1 E17K Allosteric Inhibitor, ATV-1601, in Patients With Advanced Solid Tumors

Condition: 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

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07038369

Sponsor: Atavistik Bio, Inc

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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
  8. Exclusion Criteria:
  9. Previously documented activating mutations in KRAS, NRAS, HRAS, or BRAF.
  10. Inadequate bone marrow reserve or organ function.
  11. Clinically significant abnormalities of glucose metabolism.
  12. Participants who are symptomatic or have uncontrolled brain metastases.
  13. Requires treatment with certain medications. Participants must meet other inclusion/

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.

View trial on ClinicalTrials.gov