2022-01-20
2024-04-30
2024-08-30
408
NCT05149326
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
INTERVENTIONAL
KN046 in Subjects With Advanced Pancreatic Ductal Adenocarcinoma.
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2021-11-26 | N/A | 2024-03-24 |
2021-11-26 | N/A | 2024-03-26 |
2021-12-08 | N/A | 2024-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Quadruple
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Experimental arm | DRUG: KN046
|
PLACEBO_COMPARATOR: Control arm | DRUG: placebo
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Overall Survival (OS) | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up. | up to 2 years |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Progression-free survival (PFS) | Time between randomization to date of disease progression or death due to any cause. | up to 2 years |
Overall response rate (ORR) | Complete Response or Partial Response according to RECIST | up to 2 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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