NCT05149326

KN046 in Subjects With Advanced Pancreatic Ductal Adenocarcinoma.

A Multicenter, Randomized, Double-Blind Phase III Study to Assess the Efficacy and Safety of KN046 Combined With Gemcitabine and Nab-Paclitaxel Versus Placebo Combined With Gemcitabine and Nab-Paclitaxel in First Line Advanced Pancreatic Ductal Adenocarcinoma Subjects (ENREACH-PDAC-01).

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 408 (estimated)
• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-Blind Phase III Study to compare the clinical efficacy and safety of KN046 plus gemcitabine and nab-paclitaxel versus placebo plus gemcitabine and nab-paclitaxel in subjects with advanced pancreatic ductal adenocarcinoma who have not previously received systemic treatment.

Conditions

• Advanced Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	KN046	KN046+Nab-Paclitaxel+Gemcitabine In combine therapy stage, KN046 is 5 milligram per kilogram, every 2 weeks. In maintain stage, KN046 is 5 milligram per kilogram, every 2 weeks.
DRUG	placebo	placebo+Nab-Paclitaxel+Gemcitabine In combine therapy stage, placebo is 5 milligram per kilogram, every 2 weeks. In maintain stage, placebo is 5 milligram per kilogram, every 2 weeks.

Timeline

• Start date: 2022-01-20
• Primary completion: 2024-04-30
• Completion: 2024-08-30
• First posted: 2021-12-08
• Last updated: 2024-03-26

Locations

65 sites across 1 country: China