MedTrace Logo

KN046 in Subjects With Advanced Pancreatic Ductal Adenocarcinoma.

NCT05149326 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 408

Last updated 2024-03-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Jiangsu Alphamab Biopharmaceuticals Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-20
Primary Completion
2024-04-30
Completion
2024-08-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05149326 on ClinicalTrials.gov