NCT05984602

A Phase IB Study to Determine the Safety and Tolerability of Canakinumab and Tislelizumab in Combination With Nab-Paclitaxel and Gemcitabine in the Neo-adjuvant Treatment of Patients With Pancreatic Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The goal of this Single Arm Phase Ib clinical trial is to test standard of care chemotherapy and anti PD1 and IL1b to evaluate the safety and preliminary toxicity of this quadruplet regimen prior to resection in patients with pancreatic cancer. The main objectives it aims to answer are to: * Determine the recommended Phase II dose regimen of canakinumab and tislelizumab in combination with gemcitabine and nab-paclitaxel in patients with localized pancreatic ductal adenocarcinoma. * Estimate the proportion of patients who proceed to surgical resection. * Determine the safety and tolerability of canakimumab in combination with tislelizumab, nab-paclitaxel and gemcitabine * Assess the preliminary clinical anti-tumor activity of canakimumab in combination with tislelizumab, nab-paclitaxel and gemcitabine * Assess whether therapy has any impact on surgical options Participants will have labs drawn, CT scans, and a treatment administered consisting of: * Gemcitabine * Nab-paclitaxel * Canakinumab * Tislelizumab

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Canakinumab	250 mg subcutaneous injection in prefilled syringes on day 1 of every 28-day cycle
DRUG	Tislelizumab	300 mg in a liquid vial (concentrate for intravenous (i.v.) solution) on day 1 of every 28-day cycle
DRUG	Nab-Paclitaxel	125 mg/m2 intravenous infusion on days 1, 8, 15 of every 28-day cycle
DRUG	Gemcitabine	1000 mg/m2 intravenous infusion on days 1, 8, 15 of every 28-day cycle

Timeline

• Start date: 2023-07-14
• Primary completion: 2025-09-01
• Completion: 2026-07-01
• First posted: 2023-08-09
• Last updated: 2026-03-30

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study