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Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid Tumors
NCT06150183 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this first-in-human study is to find out if BNT314 is safe when it is used alone in patients with different types of cancer. This is a dose escalation study in which patients will be assigned to multiple dose levels (DLs) of BNT314 given alone. By escalating the dose with a small group of patients, the Maximum Tolerated Dose which is the highest dose with acceptable safety and manageable side effects, or the maximum administered dose will be investigated.
Conditions Studied
Interventions
- BIOLOGICAL BNT314
Study Locations (14)
Other
- GZA Ziekenhuizen — Antwerp
- CHU de Liège — Liège
- Rigshospitalet — Copenhagen
- National Cancer Center Hospital East — Kashiwanoha
- Hospital Quironsalud Barcelona (NEXT Barcelona) — Barcelona
- Hospital Fund. Jiménez Dia — Madrid
- Hospital HM Univ. Sanchinarro, Ensayos START — Madrid
- Clinica Universidad de Navarra — Pamplona
- Royal Marsden Hospital - London — London
- The Christie Hospital — Manchester
- Northern Centre for Cancer Care — Newcastle
Michigan
- START Midwest — Grand Rapids
North Carolina
- Carolina BioOncology Institute, LLC — Huntersville
Ohio
- Cleveland Clinic — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2023-11-30 |
| Est. Completion | 2028-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06150183
The ClinicalTrials.gov registry entry for NCT06150183 describes a study currently listed as active not 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 41 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 1 condition, with Advanced Malignant Solid Tumor appearing as the primary indexed condition, and to 1 intervention — of which BNT314 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: NCT06150183 reports 14 study locations spanning 4 distinct geographic areas — top geographies include Other, Michigan, North Carolina. 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 NCT06150183 about?
NCT06150183 is a clinical study titled "Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid Tumors". The purpose of this first-in-human study is to find out if BNT314 is safe when it is used alone in patients with different types of cancer. This is a dose escalation study in which patients will be assigned to multiple dose levels (DLs) of BNT314 given alone. By escalating the dose with a small gro...
What is the current status of trial NCT06150183?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2023-11-30. Estimated completion is 2028-03.
What conditions does trial NCT06150183 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06150183?
The interventions under investigation include: BNT314 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06150183?
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 NCT06150183 being conducted?
This trial has 14 study locations across Michigan, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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