A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
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
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.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study is testing a drug called DB-1303/BNT323 — an antibody-drug conjugate that targets HER2, a protein found on the surface of certain cancer cells — in patients with advanced or metastatic solid tumors. The drug delivers chemotherapy directly to cancer cells that carry the HER2 protein.
**You may be eligible if...**
- You have an advanced solid tumor that has the HER2 protein on cancer cells (or is HER2-null for one specific cohort)
- Your cancer has returned or progressed after standard treatments
- You have at least one measurable tumor on scans
- You are in good health (ECOG performance status 0–1)
- Your heart function (ejection fraction) and organ function meet minimum requirements
- Your life expectancy is at least 3 months
**You may NOT be eligible if...**
- You have a history of significant heart failure or serious heart rhythm problems
- You have had a heart attack or unstable angina in the past 6 months
- You have clinically significant lung disease
- You have active brain metastases
- You have HIV with an AIDS-defining illness, or active viral hepatitis
- You have an unresolved serious infection requiring IV treatment
- You have a known allergy to the drug components
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
BIOLOGICALDB-1303/BNT323
Administered IV
DRUGPertuzumab Injection
Administered IV
DRUGRitonavir
Administered oral
DRUGItraconazole
Administered oral
Locations(102)
Helios Clinical Research
Cerritos, California, United States
California Research Institute
Los Angeles, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Washington Cancer Institute at MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Advanced Research LLC
Coral Springs, Florida, United States
The Oncology Institute of Hope and Innovation
Lakeland, Florida, United States
D&H Cancer Research Center LLC
Margate, Florida, United States
HCA Mercy Hospital
Miami, Florida, United States
BRCR Medical Center Inc.
Plantation, Florida, United States
BRCR Medical Center Inc.
Tamarac, Florida, United States
Southeastern Regional Medical Center, LLC
Newnan, Georgia, United States
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, United States
University of Chicago
Chicago, Illinois, United States
Women's Cancer Care
Covington, Louisiana, United States
Holy Cross Hospital
Silver Spring, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Profound Research LLC/Michigan Hematology & Oncology Consultants
Dearborn, Michigan, United States
David C. Pratt Cancer Center
St Louis, Missouri, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
Northwell Health
Lake Success, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYC Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
North Shore Hematology Oncology Associate P.C. DBA New York Cancer and Blood Specialists