New hope for Hard-to-Treat cancers: DB-1305 enters human trials

NCT ID NCT05438329

Disease control Sponsor: DualityBio Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called DB-1305/BNT325 in adults with advanced solid tumors that have not responded to standard treatments. The goal is to find a safe dose and see if it can shrink tumors. About 1,100 participants will take part in this early-phase trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 1,123 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor

Contacts and locations

Locations

Site 101

Canton, Ohio, 44718, United States
Site 102

New York, New York, 10065, United States
Site 103

Cerritos, California, 90703, United States
Site 104

Houston, Texas, 77030, United States
Site 105

Nashville, Tennessee, 37203, United States
Site 106

Detroit, Michigan, 48201, United States
Site 107

Fairfax, Virginia, 22031, United States
Site 108

Los Angeles, California, 90404, United States
Site 109

Plantation, Florida, 33322, United States
Site 110

Arlington, Texas, 76017, United States
Site 111

Honolulu, Hawaii, 96813, United States
Site 112

Pittsburgh, Pennsylvania, 15224, United States
Site 113

Mayagüez, Puerto Rico, 00682, Puerto Rico
Site 114

Margate, Florida, 33063, United States
Site 115

Houston, Texas, 77074, United States
Site 116

New York, New York, 10016, United States
Site 117

Tamarac, Florida, 33321, United States
Site 118

Oklahoma City, Oklahoma, 73104, United States
Site 119

Tyler, Texas, 75701, United States
Site 120

Miami, Florida, 33133, United States
Site 121

Wilson, North Carolina, 27895, United States
Site 122

Coral Springs, Florida, 33065, United States
Site 123

Philadelphia, Pennsylvania, 19107, United States
Site 124

Dearborn, Michigan, 48126, United States
Site 125

Royal Oak, Michigan, 48073, United States
Site 126

Ocala, Florida, 34474, United States
Site 127

Los Angeles, California, 90027, United States
Site 128

Tacoma, Washington, 98405, United States
Site 129

Las Vegas, Nevada, 89106, United States
Site 130

Westbury, New York, 11590, United States
Site 131

Washington D.C., District of Columbia, 20007, United States
Site 132

Cincinnati, Ohio, 45219, United States
Site 133

Los Angeles, California, 90067, United States
Site 134

Chicago, Illinois, 60611, United States
Site 135

Falls Church, Virginia, 19107, United States
Site 136

La Jolla, California, 92093, United States
Site 137

Sheboygan, Wisconsin, 53081, United States
Site 138

Tacoma, Washington, 98405, United States
Site 139

Bullhead City, Arizona, 86442, United States
Site 140

Orange City, Florida, 32763, United States
Site 141

St. Petersburg, Florida, 33709, United States
Site 142

Hialeah, Florida, 33013, United States
Site 160

Mineola, New York, 11501, United States
Site 201

Changchun, Jilin, 130012, China
Site 202

Zhengzhou, Henan, 450000, China
Site 203

Tianjin, Tianjin Municipality, 300060, China
Site 205

Wuhan, Hubei, 430021, China
Site 206

Chengdu, Sichuan, 611135, China
Site 207

Shanghai, Shanghai Municipality, 201315, China
Site 208

Baoding, Hebei, 071030, China
Site 209

Nanning, Guangxi, 531200, China
Site 210

Shenyang, Liaoning, 110042, China
Site 211

Bengbu, Anhui, 233099, China
Site 212

Linyi, Shandong, 276304, China
Site 213

Fuzhou, Fujian, 350001, China
Site 214

Fuzhou, Fujian, 350014, China
Site 215

Ganzhou, Jiangxi, 341000, China
Site 216

Jinan, Shandong, 250117, China
Site 217

Hefei, Anhui, 230031, China
Site 219

Guangzhou, Guangdong, 510080, China
Site 220

Taizhou, Zhejiang, 317004, China
Site 221

Guigang, Guangxi, 537100, China
Site 222

Hangzhou, Zhejiang, 310022, China
Site 223

Harbin, Heilongjiang, 150081, China
Site 224

Changsha, Hunan, 410013, China
Site 225

Guangzhou, Guangdong, 510120, China
Site 226

Lanzhou, Gansu, 730050, China
Site 227

Haikou, Hainan, 570102, China
Site 228

Wenzhou, Zhejiang, 325015, China
Site 229

Nanchang, Jiangxi, 330038, China
Site 230

Chongqing, 400030, China
Site 231

Changsha, Hunan, 410011, China
Site 232

Ürümqi, Xinjiang, 830000, China
Site 233

Nanjing, Jiangsu, 210009, China
Site 234

Guangzhou, Guangdong, 510080, China
Site 235

Nanning, Guangxi, 530021, China
Site 236

Qingdao, Shandong, 266035, China
Site 237

Jining, Shandong, 272007, China
Site 238

Taiyuan, Shanxi, 030001, China
Site 239

Anyang, Henan, 455000, China
Site 240

Kunming, Yunnan, 650118, China
Site 241

Xi'an, Shaanxi, 710100, China
Site 242

Nanchang, Jiangxi, 330029, China
Site 243

Chengde, Hebei, 067000, China
Site 244

Shanghai, 200123, China
Site 245

Dongguan, Guangdong, 523059, China
Site 246

Ganzhou, Jiangxi, 341001, China
Site 247

Linyi, Shandong, 276034, China
Site 248

Yanbian, Jilin, 133000, China
Site 249

Changchun, Jilin, 130021, China
Site 250

Nanchang, Jiangxi, 330029, China
Site 252

Changsha, Hunan, 410013, China
Site 253

Wuhan, Hubei, 430079, China

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