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
Public ClinicalTrials.gov record NCT06827236. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT06827236
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 380 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 22, 2025
- Primary completion
- Jul 31, 2029
- Completion
- Jul 31, 2029
- Last update posted
- Aug 26, 2026
2025 – 2029
United States locations
- U.S. sites
- 27
- U.S. states
- 10
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | Recruiting |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | Recruiting |
| Hematology - Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | 34952 | Recruiting |
| University Cancer & Blood Center, LLC | Athens | Georgia | 30607 | Recruiting |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | Recruiting |
| University of Illinois Hospital & Health Sciences System | Chicago | Illinois | 60612 | Recruiting |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | Recruiting |
| Brigitte Harris Cancer Pavilion BHCP | Detroit | Michigan | 48202 | Recruiting |
| START Midwest, LLC | Grand Rapids | Michigan | 49546 | Recruiting |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Memorial Sloan Kettering Cancer Center Basking Ridge | Basking Ridge | New Jersey | 07920 | Recruiting |
| Summit Medical Group | Florham Park | New Jersey | 07932 | Recruiting |
| Memorial Sloan Kettering Cancer Center Monmouth | Middletown | New Jersey | 07748 | Recruiting |
| Memorial Sloan Kettering Cancer Center Bergen | Montvale | New Jersey | 07645 | Recruiting |
| Memorial Sloan Kettering Cancer Center Westchester | Harrison | New York | 10604 | Recruiting |
| Beth Israel Comprehensive Cancer Center | New York | New York | 10011 | Recruiting |
| Mount Sinai Medical Center | New York | New York | 10019 | Recruiting |
| Icahn School of Medicine at Mount Sinai PRIME | New York | New York | 10029-6503 | Recruiting |
| Memorial Sloan Kettering Hospital | New York | New York | 10065 | Recruiting |
| Memorial Sloan Kettering Commack | New York | New York | 11725 | Recruiting |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | Recruiting |
| Memorial Sloan Kettering Cancer Center Nassau | Uniondale | New York | 11553 | Recruiting |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | Recruiting |
| Baylor Scott & White Research Institute -Texas Oncology | Dallas | Texas | 75246 | Recruiting |
| UT Southwestern Medical Center | Dallas | Texas | 75390-8896 | Recruiting |
| South Texas Accelerated Research Therapeutics (START), LLC | San Antonio | Texas | 78229 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 51 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06827236, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 26, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06827236 live on ClinicalTrials.gov.