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RECRUITING
NCT05438329
PHASE1/PHASE2

First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors

Sponsor: DualityBio Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

DB-1305/BNT325

Administered Injection of Vein (I.V.)

COMBINATION_PRODUCT

Pembrolizumab

Administered I.V.

DRUG

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