Effects of Proglumide with Chemotherapy on the Pancreatic Tumor Microenvironment: Phase 1 PROGEM Trial
Adding a drug that reshapes the tumor environment to standard chemotherapy for advanced pancreatic cancer shows safety and early signals of benefit worth pursuing further.
This Phase 1 trial found proglumide (CCK-receptor antagonist) added to standard chemotherapy was safe and showed mechanistically promising tumor microenvironment remodeling in metastatic PDAC, including increased CD8+ T cells and reduced M2-polarized macrophages at week 8. While limited by the single-arm Phase 1 design without control, the TME modulation and pain reduction signals support further investigation.
What the study was
- Study design
- Phase 1 clinical trial (single-arm, safety + biomarker)
- Population
- Gemcitabine-naive metastatic pancreatic cancer patients (mean age 68.2)
- Category
- Treatment Innovation
- Maturity
- Exploratory
- Journal
- Pharmaceutics
Why it surfaced
Phase 1 human trial with functional biomarker evidence of TME remodeling for metastatic PDAC (extreme unmet need); mechanistically novel CCK-antagonist approach; limited by Phase 1 design and small N.
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