KN046 In Subjects With Advanced Pancreatic Ductal Adenocarcinoma.

Study Overview

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

Advanced Pancreatic Ductal Adenocarcinoma

DRUG: KN046
DRUG: placebo

KN046-303

Study Record Dates

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
First Submitted 2021-11-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-03-24
First Submitted that Met QC Criteria 2021-11-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-03-26
First Posted (ACTUAL) 2021-12-08	Results First Posted N/A	Last Verified 2024-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Quadruple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Experimental arm	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.
PLACEBO_COMPARATOR: Control arm	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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Experimental arm

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.

PLACEBO_COMPARATOR: Control arm

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.

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

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:

Age ≥18, male or female;
Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
Has not received prior systemic treatment for their locally advanced or metastatic PDAC;
Has presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1);
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
Has a life expectancy of at least 3 months;
Has adequate organ function;
If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment;
If female of childbearing potential or a male subject with a partner with childbearing potential, be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 24 weeks after completion of the trial treatment.

Untreated active CNS metastasis or leptomeningeal metastasis.
Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;
Has received other anti-tumor treatment within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first trial treatment;
Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;
Curative radiation within 3 months of the first dose of trial treatment. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration of trial treatment;
Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to < 10 mg prednisone daily, inhaled steroids and topical use of steroids);
Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines);
Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;
History or current active autoimmune disease that might deteriorate when receiving an immunostimulatory agent；
Previous malignant disease History of uncontrolled intercurrent illness Prior therapy with any antibody/drug targeting T cell coregulatory proteins Known severe hypersensitivity reactions to antibody drug；
Is pregnant or breastfeeding;
Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Resources

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Clinical Trial Record