NCT05827055: ProGem

Role of Cholecystokinin Receptor Blockade on the Tumor Microenvironment in Pancreatic Cancer

Active, enrolled Phase 2 Last updated 8 June 2026

What this trial tests

Phase 2 trial testing Gemcitabine in Metastatic Pancreatic Cancer in 30 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

31 January 2024

Primary endpoint
1 January 2027

1 January 2027

Quick facts

Lead sponsor	Georgetown University
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	treatment
Enrollment	30
Start date	31 January 2024
Primary completion	1 January 2027
Estimated completion	1 January 2027
Sites	1 location across United States

Drugs / interventions tested

• Gemcitabine (gemcitabine) — full drug profile →
• Nab paclitaxel
• Proglumide — full drug profile →
• Placebo

Conditions studied

• Metastatic Pancreatic Cancer — all drugs for Metastatic Pancreatic Cancer →

Sponsor

Georgetown University

Who can join

18 and older, any sex, with Metastatic Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Safety of oral proglumide therapy at 1200mg daily dose with chemotherapy
  Time frame: 18 months
  The number of abnormal serum chemistry values occurring in those on proglumide compared to those on placebo

Sponsor's own description

This is a Phase 2 study with an open labelled lead-in study to approximately treat 30 patients \[6 subjects for Lead-in and 24 for Phase 2\] enrolled with metastatic pancreatic cancer with combination therapy using standard of care first line therapy with GEM-NAB-P (GEM 1000mg/m2 IV and NAB-P 125 mg/m2 given days 1, 8, and 15 every 28 days, and proglumide will be tested at the daily dose of 1200 mg orally given as 400 mg po TID. The lead-in study will determine the safety and tolerability of the 1200 mg daily dose of proglumide with standard of care GEM-NAB-P. If 0 or 1 of a total of 6 patients at 400mg experiences a DLT, then we will proceed to the Phase 2 randomized trial.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical Evaluation of the Pancreatic Cancer Microenvironment: Opportunities and Challenges.
   Szczepanski JM, Rudolf MA, Shi J. · · 2024 · cited 7× · PMID 38398185 · DOI 10.3390/cancers16040794
2. Mechanistic Insights into Proglumide's Role in Immune Cell Efficacy and Response to Immune Checkpoint Inhibitor Therapy in Hepatocellular Carcinoma.
   Doneparthi PS, Cao H, Chen W, Dou W, et al · · 2025 · cited 1× · PMID 41008842 · DOI 10.3390/cancers17182998
3. Effects of Proglumide with Chemotherapy on the Pancreatic Tumor Microenvironment: Phase 1 PROGEM Trial.
   Smith JP, Nkulikiyimana GC, Cao H, Chen W, et al · · 2026 · PMID 41900865 · DOI 10.3390/pharmaceutics18030379
4. Downregulation of the CCK-B Receptor in Pancreatic Stellate Cells Blocks Molecular Proliferative Pathways and Increases Apoptosis to Decrease Pancreatic Cancer Growth In Vitro.
   Ortega M, Agena E, Chen W, Cao H, et al · · 2025 · PMID 41373844 · DOI 10.3390/ijms262311699