On May 5, 2026 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical-stage biotechnology company, reported that the first patient was dosed in Study FTH-PIK-101 (NCT07558733), a Phase 1b/2 trial of PIKTOR in patients with HR+/HER2- advanced breast cancer. PIKTOR, an investigational, all-oral combination of serabelisib and sapanisertib, is designed to inhibit multiple nodes of the PI3K/AKT/mTOR pathway through PI3K-alpha and dual mTORC1/2 targeting, and became Sensei’s lead program after the company acquired Faeth Therapeutics in February 2026.
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Patients with HR+/HER2- advanced breast cancer whose tumors stop responding to current therapies have few effective options, particularly when their cancer is driven by the PI3K/AKT/mTOR signaling pathway, a network of growth and survival signals that is altered in approximately half of HR+/HER2- cases.¹ Study FTH-PIK-101, titled "Open-Label Umbrella Study to Evaluate Safety and Efficacy of Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients with HR+/HER2- Advanced or Metastatic Breast Cancer," is evaluating PIKTOR across HR+/HER2-advanced breast cancer patients, regardless of mutational status.
The study is a multi-center, dose-escalation Phase 1b/2 trial evaluating sapanisertib and serabelisib (PIKTOR) in combination with fulvestrant and/or other anticancer therapies in patients with HR+/HER2- advanced or metastatic breast cancer.
Approved drugs that target this pathway each block only one component, which often allows the cancer to reroute its growth signals through the parts that remain active. PIKTOR takes a different approach, combining two oral drugs, serabelisib (which blocks PI3K-alpha) and sapanisertib (which blocks mTORC1 and mTORC2), to target multiple nodes of the pathway simultaneously.
PIKTOR has already been tested in cancer patients. In a completed investigator-initiated Phase 1b study (NCT03154294), patients with advanced breast, endometrial and ovarian tumors who had failed an average of four prior treatments and were largely out of standard options received PIKTOR plus paclitaxel. Nearly half responded (47% overall response rate, n=15). Among patients whose tumors carried PI3K pathway mutations, 71% responded. Three patients had complete responses, all in endometrial cancer.² Sapanisertib in combination with fulvestrant has also shown activity in HR+/HER2- advanced breast cancer in an earlier Phase 2 study.³
"In our earlier trial, patients who had exhausted multiple lines of therapy, including chemotherapy, responded to the PIKTOR plus paclitaxel combination, and several had complete responses," said Anand Parikh, Chief Operating Officer of Sensei Biotherapeutics. "PIK-101 now takes that same oral combination into breast cancer, where a large share of tumors carry the pathway alterations that PIKTOR is designed to target."
As part of its broader clinical development program for PIKTOR, Sensei is also conducting Study FTH-PIK-201, an ongoing multicenter, open-label, single-arm Phase 2 study (n≈40) in patients with advanced endometrial cancer.
(Press release, Sensei Biotherapeutics, MAY 5, 2026, View Source [SID1234665131])