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First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors
Sponsor: DualityBio Inc.
Summary
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1305/BNT325 in subjects with advanced 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-1305 in Subjects With Advanced/Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1123
Start Date
2022-07-19
Completion Date
2025-06-30
Last Updated
2025-02-27
Healthy Volunteers
No
Conditions
Interventions
DB-1305/BNT325
Administered Injection of Vein (I.V.)
Pembrolizumab
Administered I.V.
BNT327
Administered I.V.
Locations (30)
Site 103
Cerritos, California, United States
Site 108
Los Angeles, California, United States
D&H Cancer Research Center Llc
Margate, Florida, United States
Site 109
Plantation, Florida, United States
BRCR Medical Center Inc.
Tamarac, Florida, United States
Site 106
Detroit, Michigan, United States
Site 102
New York, New York, United States
Site 101
Canton, Ohio, United States
Site 105
Nashville, Tennessee, United States
Site 110
Arlington, Texas, United States
Site 104
Houston, Texas, United States
Site 107
Fairfax, Virginia, United States
Site 211
Bengbu, Anhui, China
Site 217
Hefei, Anhui, China
Site 213
Fuzhou, Fujian, China
Site 209
Nanning, Guangxi, China
Site 221
Guigang, Guanxi, China
Site 202
Zhengzhou, Henan, China
Site 205
Wuhan, Hubei, China
Site 208
Ganzhou, Jiangxi, China
Site 201
Changchun, Jilin, China
Site 210
Shenyang, Liaoning, China
Site 216
Jinan, Shandong, China
Site 212
Linyi, Shandong, China
Site 207
Shanghai, Shanghai Municipality, China
Site 206
Chengdu, Sichuan, China
Site 203
Tianjin, Tianjin Municipality, China
Site 220
Taizhou, Zhejiang, China
Site 219
Guangzhou, China
BRCR GLOBAL Puerto Rico LLC.
Mayagüez, Puerto Rico