RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-07-19

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05438329

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Tyler McCullars

CONTACT

(404) 954-1826

tyler.mccullars@tigermedgrp.com

Cathy Li

CONTACT

201-503-5410

cathy.li@dualitybiologics.com

Principal Investigator

Lily Hu

STUDY_DIRECTOR

DualityBio Inc.

Study Locations (Sites)

Site 103

Cerritos, California, 90703

United States

Site 108

Los Angeles, California, 90095

United States

D&H Cancer Research Center Llc

Margate, Florida, 33063

United States

Site 109

Plantation, Florida, 33322

United States

BRCR Medical Center Inc.

Tamarac, Florida, 33321

United States

Site 106

Detroit, Michigan, 48201

United States

Site 102

New York, New York, 10065

United States

Site 101

Canton, Ohio, 44718

United States

Site 105

Nashville, Tennessee, 37203

United States

Site 110

Arlington, Texas, 76017

United States

Site 104

Houston, Texas, 77030

United States

Site 107

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: DualityBio Inc.

Lily Hu, STUDY_DIRECTOR, DualityBio Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-19

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2022-07-19

Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumor