Spots Global Cancer Trial Database for A Study of DB-1310 in Advanced/Metastatic Solid Tumors
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Trial Identification
Brief Title: A Study of DB-1310 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-1310 in Subjects With Advanced/Metastatic Solid Tumors
Study ID: NCT05785741
Conditions
Interventions
Study Description
Brief Summary: This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1310 in subjects with advanced solid tumors.
Detailed Description: This is a multicenter, non-randomized, open-label, multiple-dose, FIH Phase 1/2a study. Phase 1 adopts the standard "3+3" design to identify the MTD and/or RP2D; Phase 2a is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors treated with DB-1310 as monotherapy or in combination with trastuzumab.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California, Davis Comprehensive Cancer Center, Sacramento, California, United States
UCLA Hematology/Oncology - Santa Monica, Santa Monica, California, United States
D&H Cancer Research Center LLC, Margate, Florida, United States
Sarah Cannon Research Institute at Florida Cancer Specialists, Orlando, Florida, United States
BRCR global, Plantation, Florida, United States
Florida Cancer Specialists, Sarasota, Florida, United States
BRCR Medical Center Inc., Tamarac, Florida, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Health System, Detroit, Michigan, United States
Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center, Cincinnati, Ohio, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
NEXT Virginia, Fairfax, Virginia, United States
Henan Cancer Hospital, Zhengzhou, Henan, China
Hunan cancer hospital, Changsha, Hunan, China
Jiangsu Province hospital, Nanjing, Jiangsu, China
Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China
The first hospital of Jilin University, Changchun, Jilin, China
The First Hospital of China Medical University, Shenyang, Liaoning, China
Shanghai Chest Hospital, Shanghai, Shanghai, China
Sichuan Provincial People's Hospital, Chendu, Sichuan, China
Contact Details
Name: Raymond Zhao, MD
Affiliation: DualityBio Inc.
Role: STUDY_DIRECTOR
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