RECRUITING

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

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Conditions

HER2-positive Advanced Solid TumorHER2HER2-positiveHER2-positive Breast CancerHER2-positive Gastric CancerHER2-positive Endometrial CancerHER2-positive Biliary Tract CancerHER2 lowHER2 highmetastatic cancerHER2-positive GEJUterine serous papillary carcinomaUSPCrecurrent cancercarcinomaneoplasmsbreast neoplasmsgastrointestinal neoplasmsendometrial neoplasmsbiliary tract neoplasmsAntineoplastic Agents, Biologicalstomach cancerbile duct cancerCholangiocarcinomaliver cancerliver neoplasmsNSCLCNon-Small Cell Lung CancerNSCLC HER2 mutationHER2 Low Breast Cancer

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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-1303/BNT323 in subjects with advanced solid tumors that express HER2.

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-1303/BNT323 in Patients with Advanced/Metastatic Solid Tumors

Quick Facts

Study Start:2022-01-31
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05150691

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 CriteriaExclusion Criteria
  1. * 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.
  2. * At least 1 measurable lesion (per RECIST 1.1)
  3. * Provide signed informed consent
  4. * ECOG performance status (PS) of 0-1.
  5. * LVEF ≥ 50% by ECHO or MUGA
  6. * Adequate organ functions
  7. * Provide pre-existing diagnosis of HER2 status or resected tumor samples or undergo fresh tumor biopsy for HER2 testing.
  8. * Life expectancy of ≥ 3 months.
  9. 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.
  1. * History of symptomatic CHF (New York Heart Association \[NYHA\] classes II-IV) or serious cardiac arrhythmia requiring treatment.
  2. * History of myocardial infarction or unstable angina within 6 months before Day 1.
  3. * Average QTcF \> 450 ms in males and \> 470 ms in females
  4. * History of clinically significant lung diseases
  5. * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
  6. * HIV infection with AIDS defining illness or active viral hepatitis.
  7. * Clinically active brain metastases
  8. * Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0, Grade ≤ 1 or baseline.
  9. * A known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
  10. * 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.

Contacts and Locations

Study Contact

Britney Winterberger
CONTACT
+1-513-403-8568
britney.winterberger@tigermedgrp.com

Study Locations (Sites)

TOI Clinical Research
Cerritos, California, 90703
United States
California Research Institute
Los Angeles, California, 90027
United States
Washington Cancer Institute at MedStar Washington Hospital Center
Washington, D.C., District of Columbia, 20010
United States
Advanced Research LLC
Coral Springs, Florida, 33065
United States
The Oncology Institute of Hope and Innovation
Lakeland, Florida, 33812
United States
D&H Cancer Research Center LLC
Margate, Florida, 33063
United States
HCA Mercy Hospital
Miami, Florida, 33133
United States
BRCR Medical Center Inc.
Plantation, Florida, 33322
United States
BRCR Medical Center Inc.
Tamarac, Florida, 33321
United States
Southeastern Regional Medical Center, LLC
Newnan, Georgia, 30265
United States
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, 96826
United States
University of Chicago
Chicago, Illinois, 60637
United States
Women's Cancer Care
Covington, Louisiana, 70433
United States
Holy Cross Hospital
Silver Spring, Maryland, 20910
United States
Massachusetts General Hospital
Boston, Massachusetts, 02214
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Profound Research LLC/Michigan Hematology & Oncology Consultants
Dearborn, Michigan, 48126
United States
David C. Pratt Cancer Center
Saint Louis, Missouri, 63141
United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89106
United States
Northwell Health
Lake Success, New York, 11042
United States
Laura & Isaac Perlmutter Cancer Center at NYC Langone Health
New York, New York, 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
North Shore Hematology Oncology Associate P.C. DBA New York Cancer and Blood Specialists
Shirley, New York, 11967
United States
Regional Medical Oncology Center
Wilson, North Carolina, 27893
United States
Gabrail Cancer Center
Canton, Ohio, 44718
United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104
United States
Rittenhouse Hematology Oncology
Philadelphia, Pennsylvania, 19107
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
AHN West Penn Hospital
Pittsburgh, Pennsylvania, 15224
United States
Tennessee Oncology
Nashville, Tennessee, 37203
United States
Clinical Trial Network
Houston, Texas, 77074
United States
Oncology and Hematology of South Texas, PA
Laredo, Texas, 78041
United States
NEXT Virginia
Fairfax, Virginia, 22031
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: 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 Date2022-01-31
Study Completion Date2027-10

Study Record Updates

Study Start Date2022-01-31
Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

  • HER2
  • HER2-positive
  • HER2-positive Breast Cancer
  • HER2-positive Gastric Cancer
  • HER2-positive Endometrial Cancer
  • HER2-positive Biliary Tract Cancer
  • HER2-positive Advanced Solid Tumor
  • HER2 low
  • HER2 high
  • metastatic cancer
  • HER2-positive GEJ
  • Uterine serous papillary carcinoma
  • USPC
  • recurrent cancer
  • carcinoma
  • neoplasms
  • breast neoplasms
  • gastrointestinal neoplasms
  • endometrial neoplasms
  • biliary tract neoplasms
  • Antineoplastic Agents, Biological
  • stomach cancer
  • bile duct cancer
  • Cholangiocarcinoma
  • liver cancer
  • liver neoplasms
  • NSCLC
  • Non-Small Cell Lung Cancer
  • NSCLC HER2 mutation
  • HER2 Low Breast Cancer

Additional Relevant MeSH Terms

  • HER2-positive Advanced Solid Tumor