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NCT06750185 · ClinicalTrials.gov registry record · Phase 1

Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors

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

Recruiting
Registry status
Phase 1
Development phase
39
Enrollment target
11
Study locations

NCT06750185 is a Phase 1 study of Advanced Solid Tumor that is actively recruiting participants, run by BioNTech SE. The registered enrollment target is 39 participants, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (80% lower). The trial reports 11 study locations across 8 states.

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The verdict

NCT06750185, a Phase 1 study of Advanced Solid Tumor, is actively recruiting participants, sponsored by BioNTech SE.

RECRUITING
Registry status
Phase 1
Development phase
39 participants
Enrollment target
11
Study locations

Study Summary

This is a first-in-human (FIH), open-label, multiple-site, dose escalation study which will evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of increasing doses of BNT317 in participants with advanced solid tumors.

Conditions Studied

Advanced Solid Tumor

Interventions

  • BIOLOGICAL BNT317 DL1
  • BIOLOGICAL BNT317 DL2
  • BIOLOGICAL BNT317 DL3
  • BIOLOGICAL BNT317 DL4
  • BIOLOGICAL BNT317 DL5 (intermediate)

Study Locations (11)

Other

  • Cancer Research SA - Adelaide
  • Monash Medical Centre Clayton - Clayton
  • Scientia Clinical Research - Randwick

Texas

  • Mary Crowley Cancer Research - Dallas
  • South Texas Accelerated Research Therapeutics (START), LLC - San Antonio

Kentucky

  • Norton Cancer Institute PARENT - Louisville

Michigan

  • START Midwest - Grand Rapids

North Carolina

  • Carolina BioOncology Institute, LLC - Huntersville

Rhode Island

  • Rhode Island Hospital - East Providence

South Carolina

  • MUSC Hollings Cancer Center - Charleston

Queensland

  • Tasman Oncology Research Ltd - Southport

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2025-01-13
Est. Completion 2028-06
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 NCT06750185

The ClinicalTrials.gov registry entry for NCT06750185 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (80% 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 Solid Tumor appearing as the primary indexed condition, and to 5 interventions - of which BNT317 DL1 is the first listed.

NCT06750185 reports 11 study locations spanning 8 distinct geographic areas - top geographies include Other, Texas, Kentucky.

Frequently Asked Questions

What is clinical trial NCT06750185 about?

NCT06750185 is a clinical study titled "Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors". This is a first-in-human (FIH), open-label, multiple-site, dose escalation study which will evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of increasing doses of BNT317 in participants with advanced solid tumors.

What is the current status of trial NCT06750185?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2025-01-13. Estimated completion is 2028-06.

What conditions does trial NCT06750185 study?

This clinical trial studies the following conditions: Advanced Solid Tumor.

What interventions are being tested in trial NCT06750185?

The interventions under investigation include: BNT317 DL1 (BIOLOGICAL), BNT317 DL2 (BIOLOGICAL), BNT317 DL3 (BIOLOGICAL), BNT317 DL4 (BIOLOGICAL), BNT317 DL5 (intermediate) (BIOLOGICAL).

Who is sponsoring clinical trial NCT06750185?

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

Where is trial NCT06750185 being conducted?

This trial has 11 study locations across Kentucky, Michigan, North Carolina, Rhode Island, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.