A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

Description

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.

Conditions

HER2-positive Advanced Solid Tumor

Talk to us

Study Overview

On this page

Study Details

Study overview

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303/BNT323 in Patients with Advanced/Metastatic Solid Tumors

A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

Condition
HER2-positive Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Cerritos

TOI Clinical Research, Cerritos, California, United States, 90703

Los Angeles

California Research Institute, Los Angeles, California, United States, 90027

Washington, D.C.

Washington Cancer Institute at MedStar Washington Hospital Center, Washington, D.C., District of Columbia, United States, 20010

Coral Springs

Advanced Research LLC, Coral Springs, Florida, United States, 33065

Lakeland

The Oncology Institute of Hope and Innovation, Lakeland, Florida, United States, 33812

Margate

D&H Cancer Research Center LLC, Margate, Florida, United States, 33063

Miami

HCA Mercy Hospital, Miami, Florida, United States, 33133

Plantation

BRCR Medical Center Inc., Plantation, Florida, United States, 33322

Tamarac

BRCR Medical Center Inc., Tamarac, Florida, United States, 33321

Newnan

Southeastern Regional Medical Center, LLC, Newnan, Georgia, United States, 30265

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Has a pathologically documented HER2-positive or HER2-expressing (except for cohort 2h where the requirement is HER2-null), advanced/unresectable, recurrent, or metastatic malignant solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
  • * At least 1 measurable lesion (per RECIST 1.1)
  • * Provide signed informed consent
  • * ECOG performance status (PS) of 0-1.
  • * LVEF ≥ 50% by ECHO or MUGA
  • * Adequate organ functions
  • * Provide pre-existing diagnosis of HER2 status or resected tumor samples or undergo fresh tumor biopsy for HER2 testing.
  • * Life expectancy of ≥ 3 months.
  • 1. Has pathologically documented advanced/unresectable, recurrent, or metastatic EC (including UCS and USPC) and has progressed on or after at least 1 line of systemic treatment including platinum-based therapy and exposure to ICI but no more than prior 3 lines of therapy for advanced/unresectable, or metastatic disease. Note: endocrine therapy will not qualify as a systemic therapy line.
  • * History of symptomatic CHF (New York Heart Association \[NYHA\] classes II-IV) or serious cardiac arrhythmia requiring treatment.
  • * History of myocardial infarction or unstable angina within 6 months before Day 1.
  • * Average QTcF \> 450 ms in males and \> 470 ms in females
  • * History of clinically significant lung diseases
  • * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
  • * HIV infection with AIDS defining illness or active viral hepatitis.
  • * Clinically active brain metastases
  • * Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0, Grade ≤ 1 or baseline.
  • * A known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
  • * Part 2 (expansion) Only:Multiple primary malignancies within 3 years, except adequately resected non- melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

DualityBio Inc.,

Study Record Dates

2027-10