TAS-117 in Patients With Advanced Solid Tumors Harboring Germline PTEN Mutations

Inclusion Criteria

1. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
2. Dose Escalation in Part A

   1. ≥18 years of age.
   2. Histologically or cytologically confirmed advanced or metastatic solid tumors
   3. Has progressed after standard treatment for advanced or metastatic disease or was intolerant to or ineligible for available standard therapies.
   4. Patients with solid tumors irrespective of gene alterations.
   5. Patients with at least one measurable or non-measurable lesion per RECIST1.1
3. Dose and Regimen Confirmation in Part A and Phase 2 (Part B)

   1. ≥12 years of age. Patients age ≥12 and \<18 years must have a body weight of ≥40 kg.
   2. Histologically confirmed advanced or metastatic solid tumors.
   3. Has progressed after standard treatment for advanced or metastatic disease or was intolerant or ineligible to available standard therapies.
   4. Patients with locally confirmed germline PTEN inactivating mutations determined from a blood sample.
   5. Patients with at least one measurable lesion per RECIST 1.1.

Exclusion Criteria

1. History or current evidence of interstitial lung disease that requires steroid medication.
2. Current evidence of diabetes mellitus that requires insulin therapy.
3. Prior treatment with PI3K/AKT/mTOR pathway inhibitors.
4. Patients with primary brain tumor.
5. Patients with meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastasis.
6. Currently receiving chronic corticosteroid therapy of ≥10 mg/day of prednisone or its equivalent.