A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
Start Date
1/31/2022
Completion Date
10/1/2027
Summary
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.
Detailed Description
This is a multicenter, non-randomized (Except for Dose Expansion 1 and Dose Expansion 9 cohorts), open-label, multiple-dose, FIH study. The study consists of two parts: Part 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the MTD/RP2D; Part 2 is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors at the MTD/the RP2D. This study will enroll subjects with advanced/unresectable, recurrent, or metastatic HER2-expressing malignant solid tumors.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
DB-1303/BNT323
Pertuzumab Injection
Ritonavir
Itraconazole
Conditions
Locations
Helios Clinical Research
Cerritos, California 90703
United States
California Research Institute
Los Angeles, California 90027
United States
Sharp Memorial Hospital
San Diego, California 92123
United States
Washington Cancer Institute at MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010
United States
Advanced Research LLC
Coral Springs, Florida 33065
United States
The Oncology Institute of Hope and Innovation
Lakeland, Florida 33812
United States
D&H Cancer Research Center LLC
Margate, Florida 33063
United States
HCA Mercy Hospital
Miami, Florida 33133
United States
BRCR Medical Center Inc.
Plantation, Florida 33322
United States
BRCR Medical Center Inc.
Tamarac, Florida 33321
United States
Southeastern Regional Medical Center, LLC
Newnan, Georgia 30265
United States
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii 96826
United States
University of Chicago
Chicago, Illinois 60637
United States
Women's Cancer Care
Covington, Louisiana 70433
United States
Holy Cross Hospital
Silver Spring, Maryland 20910
United States
Massachusetts General Hospital
Boston, Massachusetts 02214
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Profound Research LLC/Michigan Hematology & Oncology Consultants
Dearborn, Michigan 48126
United States
David C. Pratt Cancer Center
St Louis, Missouri 63141
United States
Women's Cancer Center of Nevada
Las Vegas, Nevada 89106
United States
Northwell Health
Lake Success, New York 11042
United States
Laura & Isaac Perlmutter Cancer Center at NYC Langone Health
New York, New York 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
North Shore Hematology Oncology Associate P.C. DBA New York Cancer and Blood Specialists
Shirley, New York 11967
United States
Regional Medical Oncology Center
Wilson, North Carolina 27893
United States
Gabrail Cancer Center
Canton, Ohio 44718
United States
University of Oklahoma
Oklahoma City, Oklahoma 73104
United States
Rittenhouse Hematology Oncology
Philadelphia, Pennsylvania 19107
United States
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
AHN West Penn Hospital
Pittsburgh, Pennsylvania 15224
United States
Tennessee Oncology
Nashville, Tennessee 37203
United States
Clinical Trial Network
Houston, Texas 77074
United States
Oncology and Hematology of South Texas, PA
Laredo, Texas 78041
United States
NEXT Virginia
Fairfax, Virginia 22031
United States
Swedish Cancer Institute
Seattle, Washington 98104
United States
Scientia Clinical Research LTD
Randwick, New South Wales 2031
Australia
Macquarie Clinical Trials Unit
Sydney, New South Wales 2109
Australia
Integrated Clinical Oncology Network Pty Ltd (Icon)
South Brisbane, Queensland 4101
Australia
Monash Health
Melbourne, Victoria 3168
Australia
The first affiliated hospital of Bengbu medical college
Bengbu, Anhui
China
Anhui provincial hospital
Hefei, Anhui
China
The Second Hospital of Anhui Medical University
Hefei, Anhui
China
Beijing Cancer Hospital
Beijing, Beijing Municipality
China
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality
China
The First Hospital of Jilin University
Hongcun, Changchun
China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality
China
The First affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
China
The First affiliated hospital of Xiamen University
Xiamen, Fujian
China
Gansu Provincial Maternity and Child-care Hospital
Lanzhou, Gansu
China
Huizhou First Hospital
Guangzhou, Guangdong
China
Sun Yat-Sen Memorial Hospital of Zhongshan University
Guangzhou, Guangdong
China
The First affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong
China
Cancer Hospital of Guangxi Medical University
Nanning, Guangxi
China
The First people's hospital of Yulin
Yulin, Guangxi
China
Affiliated Hospital of Hebei University
Baoding, Hebei
China
Henan cancer Hospital
Zhengzhou, Hehan
China
Anyang Tumor Hospital
Anyang, Henan
China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
China
Union hospital Tongji Medical college Huazhong university of science and technology
Wuhan, Hubei
China
Hunan Cancer Hospital
Changsha, Hunan
China
Hunan People's Provincial Hospital
Changsha, Hunan
China
Xiangya Hospital Central South University
Changsha, Hunan
China
Changzhou Tumor Hospital
Changzhou, Jiangsu
China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu
China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu
China
Xuzhou Cancer Hospital
Xuzhou, Jiangsu
China
Jiangxi maternal and child health hospital
Nanchang, Jiangxi
China
The Third Hospital of Nanchang
Nanchang, Jiangxi
China
Jilin Cancer Hospital
Changchun, Jilin
China
Liaoning cancer hospital & Institute
Shenyang, Liaoning
China
The First Hospital of China Medical University
Shenyang, Liaoning
China
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, Shaanxi
China
Central hospital affiliated to Shandong first medical university
Jinan, Shandong
China
Jinan Central Hospital
Jinan, Shandong
China
Shandong Cancer hospital & institute
Jinan, Shandong
China
Affiliated hospital of Jining medical university
Jining, Shandong
China
Linyi Tumor Hospital
Liaocheng, Shandong
China
Zibo Central hospital
Zibo, Shandong
China
Yantai Yuhuangding Hospital
Yantai, Shangdong
China
Fudan University
Shanghai, Shanghai Municipality
China
Shanghai Tenth people's Hospital
Shanghai, Shanghai Municipality
China
The Obstetrics & Gynecology Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
China
Tianjin Medical university cancer institute & hospital
Tianjin, Tianjin Municipality
China
Yunnan Provincial Cancer Hospital
Kunming, Yunnan
China
1st affliated hospital of Zhejiang University
Hangzhou, Zhejiang
China
The second affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
China
Women's hospital school of medicine Zhejiang University
Hangzhou, Zhejiang
China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
China
BRCR Global Puerto Rico LLC.
Mayagüez, 00682
Puerto Rico
Seoul National University Bundang Hospital
Gyeonggi-do, Bundang-gu 13620
South Korea
Samsung Medical Center
Seoul, Gangnam-gu 06351
South Korea
National Cancer Center
Gyeonggi-do, Ilsandong-gu 10408
South Korea
Severance Hospital
Seoul, Seodaemun-gu 03722
South Korea
Asan Medical Center
Seoul, Songpa-gu 05505
South Korea
Taipei Veterans General Hospital
Taipei, Beitou District 11217
Taiwan
Changhua Christian Hospital
Changhua, Changhua County 50006
Taiwan
Taipei Medical University Hospital
Taipei, Xinyi District 110301
Taiwan
Taipei Medical University-Shuang Ho Hospital
Taipei, Zhonghe District 235041
Taiwan
Mackay Memorial Hospital-Taipei
Taipei, Zhongshan District 10449
Taiwan
National Taiwan University Hospital
Taipei, Zhongzheng District 100225
Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Zuoying District 81362
Taiwan