NCT06370754

Newly Emerging Immunotherapy for Pancreatic Cancer Treatment

A Phase Ib/II Platform Trial of Newly Emerging Immunotherapy for Pancreatic Cancer Treatment

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 117 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ib/II platform clinical study to evaluate the initial efficacy and safety of different novel immunotherapies in patients with advanced pancreatic cancer.

Detailed description

The cohort A/B/C included patients with unresectable locally advanced or metastatic pancreatic cancer who had previously failed at least first line gemcitabine-based system therapy.The cohort D/E/F included patients with previously untreated systemic pancreatic cancer with unresectable locally advanced or metastatic pancreatic cancer.This study plans to first explore A/B/C cohort, and then start the D/E/F cohort after determining the safety.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	JS001	240 mg by IV infusionevery 3 weeks (Q3W), given on cycle day 1.
DRUG	JS004	200 mg by IV infusion Q3W, given on cycle day 1.
DRUG	JS007	3mg/kg by IV infusion Q3W, given on cycle day 1.
DRUG	JS015	600mg by IV infusion Q3W, given on cycle day 1.
DRUG	Irinotecan Liposome Injection	60 or 70 mg/m\^2 by IV infusion every 2 weeks (Q2W), given on cycle day 1.
DRUG	5-Fluorouracil (5-FU)	2400mg/m\^2, intravenously, over 46 h on day 1, Q2W.
DRUG	Leucovorin (LV)	400mg/m\^2, intravenously, over 30 min on day 1, Q2W.
DRUG	Nab paclitaxel	125 mg/m\^2 by IV infusion Q3W, given on cycle day 1 and 8.
DRUG	Gemcitabine	1000 mg/m\^2 by IV infusion Q3W, given on cycle day 1 and 8.

Timeline

• Start date: 2024-04-30
• Primary completion: 2026-04-30
• Completion: 2027-04-30
• First posted: 2024-04-17
• Last updated: 2024-04-17

Locations

1 site across 1 country: China