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NCT06150183 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Advanced Malignant Solid Tumor, sponsored by BioNTech SE.

Active
Registry status
Phase 1
Development phase
41
Enrollment target
14
Study locations

NCT06150183 is a Phase 1 study of Advanced Malignant Solid Tumor that is active but no longer recruiting, run by BioNTech SE. The registered enrollment target is 41 participants, below the 70-participant average among 3 other Advanced Malignant Solid Tumor trials with a reported enrollment target (41% lower). The trial reports 14 study locations across 4 states.

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The verdict

NCT06150183, a Phase 1 study of Advanced Malignant Solid Tumor, is active but no longer recruiting, sponsored by BioNTech SE.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
41 participants
Enrollment target
14
Study locations

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

Advanced Malignant Solid Tumor

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

FieldValue
Enrollment Target 41 participants
Start Date 2023-11-30
Est. Completion 2028-03
Phase Phase 1

Sponsor

BioNTech SE

53 total trials

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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, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 70-participant average among 3 other Advanced Malignant Solid Tumor trials with a reported enrollment target (41% lower). The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.

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.

NCT06150183 reports 14 study locations spanning 4 distinct geographic areas - top geographies include Other, Michigan, North Carolina.

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.

What interventions are being tested in trial NCT06150183?

The interventions under investigation include: BNT314 (BIOLOGICAL).

Who is sponsoring clinical trial NCT06150183?

This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.