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RECRUITING Phase 1

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

NCT06750185 · View on ClinicalTrials.gov ↗

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

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

123 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. 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 39 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 Solid Tumor appearing as the primary indexed condition, and to 5 interventions — of which BNT317 DL1 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: NCT06750185 reports 11 study locations spanning 8 distinct geographic areas — top geographies include Other, Texas, Kentucky. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06750185?

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 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.

Related

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