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Brief Title: A Study of DB-1303 in Advanced/Metastatic Solid Tumors
Official Title: A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303 in Patients With Advanced/Metastatic Solid Tumors
Study ID: NCT05150691
Brief Summary: This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303 in subjects with advanced solid tumors that express HER2.
Detailed Description: This is a multicenter, non-randomized, 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
TOI Clinical Research, Cerritos, California, United States
Washington Cancer Institute at MedStar Washington Hospital Center, Washington, District of Columbia, United States
D&H Cancer Research Center LLC, Margate, Florida, United States
BRCR Medical Center Inc., Plantation, Florida, United States
BRCR Medical Center Inc., Tamarac, Florida, United States
Southeastern Regional Medical Center, LLC, Newnan, Georgia, United States
Kapi'olani Medical Center for Women and Children, Honolulu, Hawaii, United States
Women's Cancer Care, Covington, Louisiana, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
David C. Pratt Cancer Center, Saint Louis, Missouri, United States
Northwell Health, Lake Success, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYC Langone Health, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Gabrail Cancer Center, Canton, Ohio, United States
University of Oklahoma, Oklahoma City, Oklahoma, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Tennessee Oncology, Nashville, Tennessee, United States
Swedish Cancer Institute, Seattle, Washington, United States
Macquarie Clinical Trials Unit, Sydney, New South Wales, Australia
Integrated Clinical Oncology Network Pty Ltd (Icon), South Brisbane, Queensland, 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, China
Cancer Hospital Chinese Academy of Medical Science, Beijing, Beijing, China
The First Hospital of Jilin University, Jilian, Changchun, 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
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 People's Provincial Hospital, Changsha, Hunan, China
Affiliated Hospital of Jiangnan University, Wuxi, 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
The First Hospital of China Medical University, Shenyang, Liaoning, China
Central hospital affiliated to Shandong first medical university, Jinan, Shandong, China
Shandong Cancer hospital & institute, Jinan, Shandong, China
Linyi Tumor Hospital, Liaocheng, Shandong, China
Zibo Central hospital, Zibo, Shandong, China
Yantai Yuhuangding Hospital, Yantai, Shangdong, China
Fudan University, Shanghai, Shanghai, China
Tianjin Medical university cancer institute & hospital, Tianjin, Tianjin, China
1st affliated hospital of Zhejiang University, Hangzhou, Zhejiang, China
The second affiliated hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
BRCR Global Puerto Rico LLC., Mayaguez, , Puerto Rico