Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 · View on ClinicalTrials.gov ↗
Study Summary
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 in combination with BNT327 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).
Conditions Studied
Interventions
- DRUG BNT327
- DRUG BNT323
Study Locations (20)
Other
- Sunnybrook Health Sciences Centre — Toronto
- The First Affiliated Hospital of Bengbu Medical College — Bengbu
- Jilin Cancer Hospital — Changchun
- Sichuan Cancer Hospital — Chengdu
- Sichuan Provincial People's Hospital — Chengdu
- Huizhou First Hospital — Huizhou
- Guangxi Medical University Affiliated Tumor Hospital — Nanning
- Fudan University Shanghai Cancer — Shanghai
- Clinique Victor Hugo - Centre Jean Bernard — Le Mans
- Institut Claudius Regaud — Toulouse
- LLC Arensia Exploratory Medicine — Tbilisi
Missouri
- Saint Luke's Hospital of Kansas City — Kansas City
- Washington University School of Medicine — St Louis
California
- Beverly Hills Cancer Center — Beverly Hills
Florida
- Hematology - Oncology Associates of the Treasure Coast — Port Saint Lucie
Georgia
- Winship Cancer Institute of Emory University — Atlanta
Michigan
- START Midwest, LLC — Grand Rapids
New Jersey
- Summit Medical Group — Florham Park
New York
- Memorial Sloan Kettering Hospital — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 380 participants |
| Start Date | 2025-04-23 |
| Est. Completion | 2029-05 |
| Phase | Phase 1 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06827236
The ClinicalTrials.gov registry entry for NCT06827236 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 380 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 123 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which BNT327 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06827236 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Missouri, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06827236 about?
NCT06827236 is a clinical study titled "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". 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 in combination with BNT327 in participants with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), Human epidermal growth f...
What is the current status of trial NCT06827236?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 380 participants. The study started on 2025-04-23. Estimated completion is 2029-05.
What conditions does trial NCT06827236 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, Locally Advanced Breast Cancer, Unresectable Breast Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06827236?
The interventions under investigation include: BNT327 (DRUG), BNT323 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06827236?
This trial is sponsored by BioNTech SE, which has 123 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06827236 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.