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ACTIVE NOT RECRUITING Phase 2

Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy

NCT06449222 · View on ClinicalTrials.gov ↗

Study Summary

This study is a Phase II, multi-site, randomized, open-label clinical study to evaluate the safety, efficacy, and pharmacokinetics (PK) of BNT327 at two dose levels in combination with chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic triple-negative breast cancer (mTNBC).

Interventions

  • DRUG Carboplatin
  • DRUG Gemcitabine
  • DRUG BNT327 Dose Level 1 (DL1)
  • DRUG BNT327 Dose Level 1 (DL2)
  • DRUG Nab-placlitaxel

Study Locations (20)

Other

  • Peninsula Oncology Centre — Frankston
  • Peter MacCallum Cancer Centre — Melbourne
  • Baskent Universitesi Tip Fakultesi Adana Hastanesi — Adana
  • Medical Park Seyhan Hospital — Adana
  • Sakarya University - Faculty of Medicine — Adapazarı
  • Hacettepe Universitesi Kanser Enstitusu — Ankara
  • Sbu Dr.A.Y. Ankara Onkoloji SUAM — Ankara

California

  • Beverly Hills Cancer Center — Beverly Hills
  • Valkyrie Clinical Trials — Los Angeles
  • Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center — Palo Alto
  • Saint John's Health Center - John Wayne Cancer Institute (JWCI) — Santa Monica

Tennessee

  • The West Clinic, P.C. d/b/a West Cancer Center — Germantown
  • SCRI Oncology Partners — Nashville

Colorado

  • Rocky Mountain Cancer Centers (RMCC) — Denver

Connecticut

  • Yale University - Yale Cancer Center — New Haven

Illinois

  • Carle Foundation Hospital d/b/a Carle Cancer Center — Urbana

Minnesota

  • HealthPartners Regions Specialty Clinics — Saint Louis Park

New Jersey

  • Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey) — New Brunswick

Trial Details

FieldValue
Enrollment Target 83 participants
Start Date 2024-08-26
Est. Completion 2029-06
Phase Phase 2

Sponsor

BioNTech SE

123 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06449222

The ClinicalTrials.gov registry entry for NCT06449222 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 83 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 Triple Negative Breast Cancer appearing as the primary indexed condition, and to 5 interventions — of which Carboplatin 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: NCT06449222 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Tennessee. 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 NCT06449222 about?

NCT06449222 is a clinical study titled "Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy". This study is a Phase II, multi-site, randomized, open-label clinical study to evaluate the safety, efficacy, and pharmacokinetics (PK) of BNT327 at two dose levels in combination with chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic tr...

What is the current status of trial NCT06449222?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2024-08-26. Estimated completion is 2029-06.

What conditions does trial NCT06449222 study?

This clinical trial studies the following conditions: Triple Negative Breast Cancer, Locally Advanced Breast Cancer, Metastatic Triple Negative Breast Cancers. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06449222?

The interventions under investigation include: Carboplatin (DRUG), Gemcitabine (DRUG), BNT327 Dose Level 1 (DL1) (DRUG), BNT327 Dose Level 1 (DL2) (DRUG), Nab-placlitaxel (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06449222?

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 NCT06449222 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial