Protocol: ECOG – EAY191-S3
Please Note: Below is only brief eligibility, please contact the Genesys Hurley Cancer Institute Research Department at (810) 762-8181, (810) 762-8079, (810) 762-8038 to discuss full eligibility requirements.
Eligibility:
- Participants must be enrolled on the ComboMATCH Master Registration Trial EAY191.
- Participants must have an activating AKT mutation (a known mutation in AKT1, AKT2, or AKT3, a single nucleotide variant, insertion, or deletion) as determined by the ComboMATCH screening assessment.
- Participants must not have an activating KRAS, NRAS, HRAS, or BRAF mutation (a single nucleotide variant, insertion, or deletion) as determined by the ComboMATCH
screening assessment. - Participants must have disease that can be safely biopsied and agree to a pretreatment biopsy or have archival tissue available from within 12 months prior to the
date of registration on the ComboMATCH Registration Trial (EAY191). - Participants must have a histologically confirmed non-breast solid malignancy.
- Participants must have locally advanced, unresectable, or metastatic disease in the opinion of the treating investigator.
- Participants must have measurable disease.
- Participants must have progressed within 6 months of taxane-based therapy in the neoadjuvant/adjuvant or metastatic setting.
- Participants must not have received any prior AKT inhibitor (e.g., capivasertib or ipatasertib); prior PI3K/mTOR inhibitor is acceptable
- Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic, radiation, or hormonal therapy for cancer treatment while
receiving treatment on this study. - Participants must be ≥ 18 years of age.
- Participants must have a Zubrod performance status of 0-2 within 28 days prior to registration.
- Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) must not have a potential to interfere with the
safety or efficacy assessment of the investigational regimen.