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ACTIVE NOT 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

2027-09-10

Last Updated

2026-05-12

Healthy Volunteers

Conditions

Advanced Solid Tumor

Interventions

DRUG

DB-1305/BNT325

Administered Injection of Vein (I.V.)

COMBINATION_PRODUCT

Pembrolizumab

Administered I.V.

DRUG

BNT327

Administered I.V.

Inclusion Criteria: * Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent). * Histologically or cytologically confirmed unresectable advanced/ metastatic solid tumors who have relapsed or progressed on or after standard systemic treatments or for which no standard treatment is available. * At least one measurable lesion as assessed by the investigator according to RECIST version 1.1 criteria. * Has a life expectancy of ≥ 3 months. * Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1. * Has Left Ventricular Ejection Fraction (LVEF) ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment. * Has adequate organ functions within 7 days prior to Day 1 of Cycle 1. * Has adequate treatment washout period prior to Day 1 of Cycle 1. * Is willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of Trop-2 level and other biomarkers if not contraindicated. * Is capable of comprehending study procedures and risks outlined in the informed consent and able to provide written consent and agree to comply with the requirements of the study and the schedule of assessments. Exclusion Criteria: * Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association \[NYHA\] classes II-IV) or serious cardiac arrhythmia requiring treatment. * Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment. * Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \> 470 millisecond (ms) in males and females based on a 12-lead electrocardiogram (ECG) in triplicate. * Has a medical history of non-infectious Interstitial Lung Diseases (ILD)/pneumonitis or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. * Has a lung-specific intercurrent clinically significant illness. * Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals. * Subjects have human immunodeficiency virus (HIV) infection with acquired immune deficiency syndrome (AIDS) defining illness are not eligible for enrollment; However, subjects have had HIV infection with a cluster of differentiation 4 (CD4)+ T cell count \> 350 cells/µL and no history of an AIDS-defining illness are eligible for entry. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (93)

Site 139

Bullhead City, Arizona, United States

Site 103

Cerritos, California, United States

Site 136

La Jolla, California, United States

Site 127

Los Angeles, California, United States

Site 133

Los Angeles, California, United States

Site 108

Los Angeles, California, United States

Site 131

Washington D.C., District of Columbia, United States

Site 122

Coral Springs, Florida, United States

Site 142

Hialeah, Florida, United States

Site 114

Margate, Florida, United States

Site 120

Miami, Florida, United States

Site 126

Ocala, Florida, United States

Site 140

Orange City, Florida, United States

Site 109

Plantation, Florida, United States

Site 141

St. Petersburg, Florida, United States

Site 117

Tamarac, Florida, United States

Site 111

Honolulu, Hawaii, United States

Site 134

Chicago, Illinois, United States

Site 124

Dearborn, Michigan, United States

Site 106

Detroit, Michigan, United States

Site 125

Royal Oak, Michigan, United States

Site 129

Las Vegas, Nevada, United States

Site 160

Mineola, New York, United States

Site 116

New York, New York, United States

Site 102

New York, New York, United States

Site 130

Westbury, New York, United States

Site 121

Wilson, North Carolina, United States

Site 101

Canton, Ohio, United States

Site 132

Cincinnati, Ohio, United States

Site 118

Oklahoma City, Oklahoma, United States

Site 123

Philadelphia, Pennsylvania, United States

Site 112

Pittsburgh, Pennsylvania, United States

Site 105

Nashville, Tennessee, United States

Site 110

Arlington, Texas, United States

Site 104

Houston, Texas, United States

Site 115

Houston, Texas, United States

Site 119

Tyler, Texas, United States

Site 107

Fairfax, Virginia, United States

Site 135

Falls Church, Virginia, United States

Site 128

Tacoma, Washington, United States

Site 138

Tacoma, Washington, United States

Site 137

Sheboygan, Wisconsin, United States

Site 211

Bengbu, Anhui, China

Site 217

Hefei, Anhui, China

Site 213

Fuzhou, Fujian, China

Site 214

Fuzhou, Fujian, China

Site 226

Lanzhou, Gansu, China

Site 245

Dongguan, Guangdong, China

Site 219

Guangzhou, Guangdong, China

Site 234

Guangzhou, Guangdong, China

Site 225

Guangzhou, Guangdong, China

Site 221

Guigang, Guangxi, China

Site 235

Nanning, Guangxi, China

Site 209

Nanning, Guangxi, China

Site 227

Haikou, Hainan, China

Site 208

Baoding, Hebei, China

Site 243

Chengde, Hebei, China

Site 223

Harbin, Heilongjiang, China

Site 239

Anyang, Henan, China

Site 202

Zhengzhou, Henan, China

Site 205

Wuhan, Hubei, China

Site 253

Wuhan, Hubei, China

Site 231

Changsha, Hunan, China

Site 224

Changsha, Hunan, China

Site 252

Changsha, Hunan, China

Site 233

Nanjing, Jiangsu, China

Site 215

Ganzhou, Jiangxi, China

Site 246

Ganzhou, Jiangxi, China

Site 242

Nanchang, Jiangxi, China

Site 250

Nanchang, Jiangxi, China

Site 229

Nanchang, Jiangxi, China

Site 201

Changchun, Jilin, China

Site 249

Changchun, Jilin, China

Site 248

Yanbian, Jilin, China

Site 210

Shenyang, Liaoning, China

Site 241

Xi'an, Shaanxi, China

Site 216

Jinan, Shandong, China

Site 237

Jining, Shandong, China

Site 247

Linyi, Shandong, China

Site 212

Linyi, Shandong, China

Site 236

Qingdao, Shandong, China

Site 207

Shanghai, Shanghai Municipality, China

Site 238

Taiyuan, Shanxi, China

Site 206

Chengdu, Sichuan, China

Site 203

Tianjin, Tianjin Municipality, China

Site 232

Ürümqi, Xinjiang, China

Site 240

Kunming, Yunnan, China

Site 222

Hangzhou, Zhejiang, China

Site 220

Taizhou, Zhejiang, China

Site 228

Wenzhou, Zhejiang, China

Site 230

Chongqing, China

Site 244

Shanghai, China

Site 113

Mayagüez, Puerto Rico, Puerto Rico

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (93)