AUSTIN, TX & PHILADELPHIA, PA — Faeth Therapeutics and The GOG Foundation, Inc. have announced a significant milestone in the fight against endometrial cancer. The first patient has been dosed in their Phase 2 clinical trial evaluating the combination of FTH-001 (serabelisib) and FTH-003 (sapanisertib), alongside paclitaxel. Known as PIKTOR, the trial represents a groundbreaking “multi-node” approach, targeting cancer metabolism through dual PI3Kɑ-mTORC1/2 inhibition.
Endometrial cancer, one of the leading causes of cancer-related deaths in women, presents substantial challenges due to its high frequency of PI3K pathway mutations, the most commonly mutated cancer pathway. Despite its prevalence, approved therapies addressing these mutations remain nonexistent. This trial seeks to evaluate the efficacy of the PIKTOR combination, which takes aim at a critical cancer pathway driving tumor metabolism.
“Thanks to Faeth’s ability to uncover novel metabolism-targeting strategies, we are positioned to leverage the PIKTOR approach for endometrial cancer and other solid tumors,” said Anand Parikh, Chief Executive Officer of Faeth Therapeutics. “Over its five decades, the GOG Foundation has established itself as a leading clinical partner against gynecologic cancers, and we are confident they will help us pave the way for the next generation of cancer treatments.”
A Promising Multi-Node Strategy
FTH-001 and FTH-003 have both shown potential in prior cancer studies. This trial builds upon the promising results of Faeth’s Phase 1b study, which demonstrated an 80% overall response rate (ORR) in patients with endometrioid endometrial cancer and 11 months of progression-free survival.
Led by Faeth’s metabolism-focused platform, the study will assess efficacy, safety, and a substudy involving a PIKTOR-diet combination, offering a potential holistic approach to treatment. Researchers hope to address the unmet needs of advanced and relapsed patients who have progressed on first-line therapies such as carboplatin.
“This unique approach to target cancer metabolism has demonstrated impressive early results. We look forward to this trial to hopefully confirm these early findings and perhaps transform the way we treat patients with endometrial cancer,” said David Starks, MD, Principal Investigator, Avera Cancer Institute and Associate Professor, University of South Dakota Sanford School of Medicine.
Addressing a Critical Gap
The partnership highlights the importance of advancing therapeutic innovation in gynecologic oncology. Endometrial cancer remains the deadliest of gynecologic malignancies, creating a pressing need for breakthrough therapies.
“Endometrial cancer is the leading cause of deaths among all gynecologic cancers. Finding better treatment options remains our highest priority,” said Brian Slomovitz, MD, Director of Gynecologic Oncology at Mount Sinai Medical Center and GOG Partners Uterine Cancer Trial Lead. “We are excited to partner with Faeth Therapeutics to further investigate this novel therapeutic approach.”
The collaboration between Faeth Therapeutics and The GOG Foundation exemplifies the growing recognition of cancer metabolism as a key target for therapeutic breakthroughs. With its focus on advanced and recurrent cases, the Phase 2 PIKTOR trial provides much-needed hope for patients navigating this challenging disease.
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