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NCT05438329 | RECRUITING | Advanced Solid Tumor

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

DualityBio Inc.

Brief 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.

Condition or disease

Advanced Solid Tumor

Intervention/treatment

DB-1305/BNT325

Pembrolizumab

BNT327

Phase

PHASE1

PHASE2

Detailed Description:

This is a multicenter, open-label, multiple-dose, first in human (FIH) study. The study consists of two parts: Part 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D); Part 2 is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors at the MTD/the RP2D. This study will enroll subjects with advanced/unresectable, recurrent, or metastatic malignant solid tumors.

Study Type : INTERVENTIONAL
Estimated Enrollment : 1123 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2022-07-19
Estimated Primary Completion Date : 2025-06-30
Estimated Study Completion Date : 2025-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors

Location Details

NCT05438329

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Site 103

Cerritos, California, United States, 90703

RECRUITING

United States, California

Site 108

Los Angeles, California, United States, 90095

RECRUITING

United States, Florida

D&H Cancer Research Center Llc

Margate, Florida, United States, 33063

RECRUITING

United States, Florida

Site 109

Plantation, Florida, United States, 33322

RECRUITING

United States, Florida

BRCR Medical Center Inc.

Tamarac, Florida, United States, 33321

RECRUITING

United States, Road cancer

Site 106

Detroit, Road cancer, United States, 48201

RECRUITING

United States, New York

Site 102

New York, New York, United States, 10065

RECRUITING

United States, Ohio

Site 101

Canton, Ohio, United States, 44718

RECRUITING

United States, Tennessee

Site 105

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

Site 110

Arlington, Texas, United States, 76017

RECRUITING

United States, Texas

Site 104

Houston, Texas, United States, 77030

RECRUITING

United States, Virginia

Site 107

Fairfax, Virginia, United States, 22031

RECRUITING

China, Anhui

Site 211

Bengbu, Anhui, China, 233099

RECRUITING

China, Anhui

Site 217

Fairy, Anhui, China, 230031

NOT YET RECRUITING

China, Fujian

Site 213

F U-axis, Fujian, China, 350001

RECRUITING

China, Guangxi

Site 209

Nanning, Guangxi, China, 531200

RECRUITING

China, Guanxi

Site 221

Guigang, Guanxi, China, 537100

RECRUITING

China, Henan

Site 202

Zhengzhou, Henan, China, 450000

NOT YET RECRUITING

China, Hubei

Site 205

Wuhan, Hubei, China, 430021

RECRUITING

China, Jiangxi

Site 208

Ganzhou, Jiangxi, China, 341006

RECRUITING

China, Jilin

Site 201

Changchun, Jilin, China, 130012

RECRUITING

China, Liaoning

Site 210

Shenyang, Liaoning, China, 110042

RECRUITING

China, Shandong

Site 216

Women, Shandong, China, 250117

RECRUITING

China, Shandong

Site 212

Linyi, Shandong, China, 276304

RECRUITING

China, Shanghai

Site 207

Shanghai, Shanghai, China, 201315

NOT YET RECRUITING

China, Sichuan

Site 206

Chengdu, Sichuan, China, 611135

RECRUITING

China, Tianjin

Site 203

Tianjin, Tianjin, China, 300060

RECRUITING

China, Zhejiang

Site 220

Taizhou, Zhejiang, China, 317004

RECRUITING

China,

Site 219

Guangzhou, China,

RECRUITING

Puerto Rico,

BRCR GLOBAL Puerto Rico LLC.

Mayaguez, Puerto Rico, 00682