KN046 in Subjects With Advanced Pancreatic Ductal Adenocarcinoma.
- Conditions
- Advanced Pancreatic Ductal Adenocarcinoma
- Interventions
- Drug: placebo
- Registration Number
- NCT05149326
- Lead Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 408
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control arm placebo - Experimental arm KN046 -
- Primary Outcome Measures
Name Time Method Overall Survival (OS) up to 2 years 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.
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) up to 2 years Time between randomization to date of disease progression or death due to any cause.
Overall response rate (ORR) up to 2 years Complete Response or Partial Response according to RECIST
Trial Locations
- Locations (65)
Affiliated Hospital of Jining Medical University
🇨🇳Jining, Shandong, China
The Second Hospital Of Anhui medical University
🇨🇳Hefei, Anhui, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Beijing Friendship Hospital
🇨🇳Beijing, Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The Southwest Hospital of AMU
🇨🇳Chongqing, Chongqing, China
The Third Affiliated Hospital of Army Medical University
🇨🇳Chongqing, Chongqing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science And Technology
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Hunan Provincial People's Hospital
🇨🇳Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
The First People's Hospital of Changzhou
🇨🇳Changzhou, Jiangsu, China
Nantong Tumor Hospital
🇨🇳Nantong, Jiangsu, China
First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
China-Japan Union Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Liaoning Cancer Hospital
🇨🇳Shenyang, Liaoning, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
The First Affiliated Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
LINYI Cancer Hospital
🇨🇳Linyi, Shandong, China
Linyi City People Hospital
🇨🇳Linyi, Shandong, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
Weifang People'S Hospital
🇨🇳Weifang, Shandong, China
Shanghai Changhai Hospital
🇨🇳Shanghai, Shanghai, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China
Shanxi Cancer hospital
🇨🇳Taiyuan, Shanxi, China
Shanxi Provincial People's Hospital
🇨🇳Taiyuan, Shanxi, China
the First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Sichuan Cancer Hospital
🇨🇳Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
The Second Affiliated Hosipital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Jiaxing Second Hospital
🇨🇳Jiaxing, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Chongqing Cancer Hospital
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Affiliated Cancer Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
The Affiliated Hospital Of XuZhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine , Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Peking Union Medical College
🇨🇳Beijing, Beijing, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital,Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Zhejiang Provincial People's hospital
🇨🇳Hangzhou, Zhejiang, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China