Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors
Public ClinicalTrials.gov record NCT06750185. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I/II, First-in-human, Open-label Trial of the Safety, Efficacy, Tolerability, Pharmacokinetics, and Immunogenicity of BNT317 in Participants With Advanced Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a first-in-human (FIH), open-label, multi-site study which will evaluate the safety, efficacy, tolerability, pharmacokinetics (PK), and immunogenicity of increasing doses of BNT317 in participants with advanced solid tumors.
Study identification
- NCT ID
- NCT06750185
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 248 participants
Conditions and interventions
Conditions
Interventions
- BNT317 DL1 Biological
- BNT317 DL2 Biological
- BNT317 DL3 Biological
- BNT317 DL4 Biological
- BNT317 DL5 Biological
- BNT317 DL6 Biological
- BNT317 selected DLA Biological
- BNT317 selected DLB Biological
- SoC chemotherapy 1 Drug
- SoC chemotherapy 2 Drug
Biological · Drug
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
- Jan 12, 2025
- Primary completion
- Mar 31, 2031
- Completion
- Mar 31, 2031
- Last update posted
- Sep 8, 2026
2025 – 2031
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Norton Cancer Institute PARENT | Louisville | Kentucky | 40202 | Recruiting |
| START Midwest | Grand Rapids | Michigan | 49546 | Active, not recruiting |
| Carolina BioOncology Institute, LLC | Huntersville | North Carolina | 28078 | Recruiting |
| Rhode Island Hospital | East Providence | Rhode Island | 02903 | Recruiting |
| MUSC Hollings Cancer Center | Charleston | South Carolina | 29425 | Recruiting |
| Mary Crowley Cancer Research | Dallas | Texas | 75230 | Recruiting |
| South Texas Accelerated Research Therapeutics (START), LLC | San Antonio | Texas | 78229 | Active, not recruiting |
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 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06750185, 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 Sep 8, 2026 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06750185 live on ClinicalTrials.gov.