Background: The primary aim of this Phase 1 clinical trial was to study the safety and dose of a cholecystokinin receptor antagonist, proglumide, in combination with gemcitabine/nab-paclitaxel (GEM-NAB-P) in patients with metastatic pancreatic cancer. Proglumide demonstrates a favorable safety profile when combined with standard chemotherapy for metastatic pancreatic cancer. Its unique ability to remodel TME and alleviate cancer-related pain highlights its potential, warranting further research.
P3, N=137, Terminated, Novartis Pharmaceuticals | Trial completion date: Jan 2027 --> Feb 2026 | Active, not recruiting --> Terminated; The study was terminated following a strategic decision to halt recruitment due to persistently slow enrollment. This decision was not driven by any new or unexpected safety concerns.
We subsequently initiated a clinical trial (chidamide and nab-paclitaxel/gemcitabine plus anti-PD-1/CTLA-4) in metastatic PDAC patients and reported its preliminary promising results. Collectively, these findings reveal a closed link between cellular senescence and PDAC metastasis, offering the potential senolytic means to improve chemo-immunotherapy efficacy.
No treatment-related mortality was found. The S-1 could be combined with GA as another potential triplet combination treatment option for advanced PDAC.