Clinical Trial

An Open-label, Multi-Center, Phase 2 Clinical Trial Evaluating Sapanisertib and Serabelisib (PIKTOR) with Paclitaxel, and a Substudy Evaluating PIKTOR with Paclitaxel plus an Insulin-Suppressing Diet, in Patients with Advanced or Recurrent Endometrial Cancer (FTH-PIK-201)

MOA: PIKTOR is a combination of sapanisertib, an mTORC1 and 2 inhibitor, and serabelisib, a PI3Kα inhibitor.

Key Eligibility Criteria:

• Histologically confirmed advanced/recurrent endometrioid
  endometrial carcinoma
• 1-4 prior systemic therapies, including plt-based chemo and an
  immune checkpoint inhibitor, separately or in combo
• PI3K/AKT/mTOR pathway gene alteration required as identified
  by historical tumor testing within the previous 5 years
• At least 1 measurable target lesion per RECIST v1.1
• Prior PI3Ki, AKTi, dual mTORC1/2i, or dual PI3K/mTORi
  excluded
• Prior mTORC1 inhibitor allowed (e.g., everolimus, temsirolimus)
• Optional insulin-suppressing diet substudy (see Page 2 for
  additional exclusion criteria)