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NCT06827236 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Metastatic Breast Cancer and Locally Advanced Breast Cancer, sponsored by BioNTech SE.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 380
- Enrollment target
- 20
- Study locations
NCT06827236: Recruiting Phase 1 study of Metastatic Breast Cancer and Locally Advanced Breast Cancer, sponsored by BioNTech SE.
NCT06827236 is a Phase 1 study of Metastatic Breast Cancer and Locally Advanced Breast Cancer that is actively recruiting participants, run by BioNTech SE. The registered enrollment target is 380 participants, above the 202-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (88% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06827236, a Phase 1 study of Metastatic Breast Cancer and Locally Advanced Breast Cancer, is actively recruiting participants, sponsored by BioNTech SE.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 380 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
By dose level.
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 |
What NCT06827236 shows while recruiting
NCT06827236 is an interventional study that assigns participants to a tested intervention. The registered 380 participants enrollment target is mid-sized for trials with a published cap, above the 202-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (88% higher).
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.
NCT06827236 names 20 study sites across 9 states, led by Other, Missouri, California.
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.
What interventions are being tested in trial NCT06827236?
The interventions under investigation include: BNT327 (DRUG), BNT323 (DRUG).
Who is sponsoring clinical trial NCT06827236?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
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
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06827236's enrollment target sits among peer trials
380 19th of 139 higher than 121 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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