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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: Recruiting Phase 1 study of Advanced Solid Tumor, sponsored by BioNTech SE.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Per dose group. During the DLT observation period.
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
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2025-01-13 |
| Est. Completion | 2028-06 |
| Phase | Phase 1 |
What NCT06750185 shows while recruiting
NCT06750185 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (80% lower).
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 lists 11 locations in 8 states (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.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06750185's enrollment target sits among peer trials
39 171st of 189 higher than 18 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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