A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer (NCT06827236)
A Phase I/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of BNT323 in Combination With BNT327 in Participants With Advanced Breast Cancer
🩺 Plain-English Summary (8th-Grade Level)
This is a Phase I/II, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination with BNT327 (also known as pumitamig and PM8002) in participants with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), Human epidermal growth factor receptor (HER)2-positive, HER2-low (immunohistochemistry \[IHC\] 1+ or IHC 2+/in situ hybridization -), HER2-ultralow (IHC 0, with membrane staining) or HER2-null breast cancer (BC), or triple-negative breast cancer (TNBC).
Who can join: Review the eligibility criteria below.
Location: Beverly Hills Cancer Center — Beverly Hills, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (78 Sites)
Showing the first 25 of 78 sites.
- Beverly Hills Cancer Center — Beverly Hills, California
- Hoag Memorial Hospital Presbyterian — Newport Beach, California
- Hematology - Oncology Associates of the Treasure Coast — Port Saint Lucie, Florida
- University Cancer & Blood Center, LLC — Athens, Georgia
- Winship Cancer Institute of Emory University — Atlanta, Georgia
- University of Illinois Hospital & Health Sciences System — Chicago, Illinois
- Karmanos Cancer Institute — Detroit, Michigan
- Brigitte Harris Cancer Pavilion BHCP — Detroit, Michigan
- START Midwest, LLC — Grand Rapids, Michigan
- Saint Luke's Hospital of Kansas City — Kansas City, Missouri
- Washington University School of Medicine — St Louis, Missouri
- Memorial Sloan Kettering Cancer Center Basking Ridge — Basking Ridge, New Jersey
- Summit Medical Group — Florham Park, New Jersey
- Memorial Sloan Kettering Cancer Center Monmouth — Middletown, New Jersey
- Memorial Sloan Kettering Cancer Center Bergen — Montvale, New Jersey
- Memorial Sloan Kettering Cancer Center Westchester — Harrison, New York
- Beth Israel Comprehensive Cancer Center — New York, New York
- Mount Sinai Medical Center — New York, New York
- Icahn School of Medicine at Mount Sinai PRIME — New York, New York
- Memorial Sloan Kettering Hospital — New York, New York
- Memorial Sloan Kettering Commack — New York, New York
- Stony Brook University Hospital — Stony Brook, New York
- Memorial Sloan Kettering Cancer Center Nassau — Uniondale, New York
- SCRI Oncology Partners — Nashville, Tennessee
- Baylor Scott & White Research Institute -Texas Oncology — Dallas, Texas
📞 Contact the Study Coordinator
Phone: (496) 131-9084
Email: patients@biontech.de
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Locally Advanced Breast Cancer
Explore by condition: All Locally Advanced Breast Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.