NCT06639724

Perioperative Fostamatinib With Gemcitabine and Nab-paclitaxel in Resectable Pancreatic Cancer

A Phase 1b Trial of Perioperative Fostamatinib With Gemcitabine and Nab-paclitaxel in Resectable Pancreatic Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1b trial evaluating the combination of Fostamatinib, a Syk kinase inhibitor currently FDA-approved for chronic idiopathic thrombocytopenia purpura (ITP), with the standard of care chemotherapy agents gemcitabine and nab-paclitaxel, for the perioperative treatment of resectable non metastatic pancreatic ductal adenocarcinoma (PDAC).

Detailed description

Although immune checkpoint inhibition has transformed the treatment of some solid malignancies, it has made minimal impact in pancreatic ductal adenocarcinoma (PDAC), which is characterized by a profoundly immunosuppressive microenvironment. Recent published work by the study investigators demonstrated that inhibition of the Syk kinase - alone and in combination with gemcitabine - in preclinical models of PDAC (animal tumor models and human tissues) reprogrammed tumor associated macrophages resulting in enhanced anti-tumor immunity. With this phase Ib study, the investigators aim to expand the preclinical findings to patients with PDAC. This study will evaluate perioperative fostamatinib in combination with standard of care chemotherapy with gemcitabine and nab-paclitaxel. Study participants will receive 4 cycles preoperatively, followed by pancreatic surgical resection and 2 cycles postoperatively. Participants will be followed long term until death or until 2 years after enrollment, whichever occurs first, to evaluate safety and efficacy of perioperative fostamatinib in combination with gemcitabine and nab-paclitaxel.

Conditions

• Pancreatic Ductal Adenocarcinoma (PDAC)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Fostamatinib in combination with chemotherapy (gemcitabine and nab-paclitaxel)	Fostamatinib is a Syk kinase inhibitor currently FDA-approved for chronic idiopathic thrombocytopenia purpura but it has not been studied in PDAC. The investigators hypothesize that Syk inhibition reprograms macrophages to an immunostimulatory phenotype in the tumor microenvironment. Thus, Syk inhibition with fostamatinib in combination with chemotherapy could improve outcomes for patients with PDAC while having a favorable safety profile.

Timeline

• Start date: 2024-12-05
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2024-10-15
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study