KN046 in Subjects With Advanced Pancreatic Ductal Adenocarcinoma.

Advanced Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05149326
• Other study ID #: KN046-303
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 20, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: March 2024
• Source: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 408
• Est. completion date: August 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Advanced Pancreatic Ductal Adenocarcinoma

Intervention

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
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.

Locations

Country	Name	City	State
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	Peking Union Medical College	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	China-Japan Union Hospital of Jilin University	Changchun	Jilin
China	The First Hospital of Jilin University	Changchun	Jilin
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	Sichuan Cancer Hospital	Chengdu	Sichuan
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	Chongqing Cancer Hospital	Chongqing	Chongqing
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	Fujian Cancer Hospital	Fuzhou	Fujian
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	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital,Sun Yat-sen University	Guangzhou	Guangdong
China	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The Second Affiliated Hosipital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Zhejiang Provincial People's hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	The Second Hospital Of Anhui medical University	Hefei	Anhui
China	Jiaxing Second Hospital	Jiaxing	Zhejiang
China	Shandong Cancer Hospital	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shandong
China	Affiliated Hospital of Jining Medical University	Jining	Shandong
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	LINYI Cancer Hospital	Linyi	Shandong
China	Linyi City People Hospital	Linyi	Shandong
China	First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Affiliated Cancer Hospital of Guangxi Medical University	Nanning	Guangxi
China	Nantong Tumor Hospital	Nantong	Jiangsu
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Shanghai Changhai Hospital	Shanghai	Shanghai
China	Yueyang Hospital of Integrated Traditional Chinese and Western Medicine , Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai
China	Liaoning Cancer Hospital	Shenyang	Liaoning
China	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Shanxi Cancer hospital	Taiyuan	Shanxi
China	Shanxi Provincial People's Hospital	Taiyuan	Shanxi
China	Weifang People'S Hospital	Weifang	Shandong
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Union Hospital Tongji Medical College Huazhong University of Science And Technology	Wuhan	Hubei
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	the First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	The Affiliated Hospital Of XuZhou Medical University	Xuzhou	Jiangsu
China	Henan Cancer Hospital	Zhengzhou	Henan
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-free survival (PFS)	Time between randomization to date of disease progression or death due to any cause.	up to 2 years
Secondary	Overall response rate (ORR)	Complete Response or Partial Response according to RECIST	up to 2 years