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

Stopped early · Phase 1

Conditions studied: Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations, Advanced or Metastatic Solid Tumors With Germline PTEN Inactivating Mutations

In brief

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of TAS-117 in patients with advanced or metastatic solid tumors (excluding primary brain tumors) harboring germline PTEN inactivating mutations.

Key facts

Study ID

NCT04770246

Run by

Taiho Oncology, Inc.

People needed

17

Starts

2021-03-31

Expected to finish

2023-03-06

Last updated by the study team

2024-09-04

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Dose Escalation in Part A
• ≥18 years of age.
• Histologically or cytologically confirmed advanced or metastatic solid tumors
• Has progressed after standard treatment for advanced or metastatic disease or was intolerant to or ineligible for available standard therapies.
• Patients with solid tumors irrespective of gene alterations.
• Patients with at least one measurable or non-measurable lesion per RECIST1.1
• Dose and Regimen Confirmation in Part A and Phase 2 (Part B)
• ≥12 years of age. Patients age ≥12 and <18 years must have a body weight of ≥40 kg.
• Histologically confirmed advanced or metastatic solid tumors.
• Has progressed after standard treatment for advanced or metastatic disease or was intolerant or ineligible to available standard therapies.
• Patients with locally confirmed germline PTEN inactivating mutations determined from a blood sample.
• Patients with at least one measurable lesion per RECIST 1.1.

You may not qualify if…

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

Where it is running

• Sarcoma Oncology Research Center — Santa Monica, California, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Cleveland Clinic Lerner Research Institute — Cleveland, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
• Medical University of Vienna — Vienna, Austria
• Institut Gustave Roussy — Villejuif, Île-de-France Region, France
• Sarah Cannon Research Institute — London, United Kingdom

Full record on ClinicalTrials.gov

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