NCT06229496

Dose Escalation and Dose Expansion Study of GAS in Subjects With Metastatic Pancreatic Adenocarcinoma

A Phase 1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of S-1 in Combination With Nab-paclitaxel and Gemcitabine (GAS) in Subjects With Metastatic Pancreatic Adenocarcinoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1b, open-label, multicenter, dose escalation and dose expansion study of S-1 in combination with nab-paclitaxel and gemcitabine (GAS) in subjects with metastatic pancreatic adenocarcinoma. This study is a dose escalation and dose expansion study with the objective to establish the MTD and/or RP2D and/or DLT of nab-paclitaxel and gemcitabine in combination with a body surface area(BSA)-based dose of S-1 in subject with metastatic pancreatic adenocarcinoma.

Detailed description

Pancreatic ductal adenocarcinoma (PDAC) is the seventh leading cause of cancer- related death worldwide as the second leading cause of cancer mortality in the United States by 2030 . The overall 5-year survival rate is around 5% for advanced PDAC and 15-30% for resected PDAC. While recent advances have emerged in precision medicine and immunotherapy in a variety of cancer types, unfortunately these drugs are not applicable to most patients with PDAC. To date, polychemotherapy combinations remain the mainstay of systemic treatments for advanced PDAC. Of note, FOLFIRINOX is a triplet combination regimen while nab-Paclitaxel and gemcitabine is a doublet combination. Both NALIRIFOX and FOLFIRINOX showed the same median OS with about 11.1 months from NAPOLI 3 and PRODIGE4 trials, respectively, demonstrating the biologically comparable anti-tumor effects. On the other hand, the median OS of 8.5 months of gemcitabine plus nab-paclitaxel raised the question-would it be possible to add the third active drug in this doublet combination to achieve more potential efficacy, being comparable with triplet combination such as FOLFIRINOX or NALIRIFOX. Therefore, in this study the investigator aimed to investigate whether adding S-1 to nab-paclitaxel and gemcitabine as GAS regimen can be a potential triplet combination.

Conditions

• Metastatic Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Gemcitabine 800mg/m2 + Nab-paclitaxel 100mg/m2 + S-1 (dose according to BSA)	Dose escalation study-dose level 1
COMBINATION_PRODUCT	Gemcitabine 800mg/m2 + Nab-paclitaxel 125mg/m2 + S-1 (dose according to BSA)	Dose escalation study-dose level 2
COMBINATION_PRODUCT	Gemcitabine 1000mg/m2 + Nab-paclitaxel 125mg/m2 + S-1 (dose according to BSA)	Dose escalation study-dose level 3

Timeline

• Start date: 2023-08-01
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2024-01-29
• Last updated: 2024-01-29

Locations

2 sites across 1 country: Taiwan