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Active, not recruiting Phase 1 Interventional

Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid Tumors

ClinicalTrials.gov ID: NCT06150183

Public ClinicalTrials.gov record NCT06150183. 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.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 8:28 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A First-in-Human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate the Safety and Preliminary Efficacy of BNT314 as Monotherapy in Patients With Advanced Malignant Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06150183
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
BioNTech SE
Industry
Enrollment
41 participants

Conditions and interventions

Interventions

Biological

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
Nov 29, 2023
Primary completion
May 31, 2027
Completion
Feb 29, 2028
Last update posted
Jan 22, 2026

2023 – 2028

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
START Midwest Grand Rapids Michigan 49546
Carolina BioOncology Institute, LLC Huntersville North Carolina 28078
Cleveland Clinic Cleveland Ohio 44195

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 11 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06150183, 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 Jan 22, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06150183 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →