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RECRUITING
NCT06750185
PHASE1

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

Sponsor: BioNTech SE

View on ClinicalTrials.gov

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.

Official title: A Phase I, First-in-human, Open-label, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BNT317 in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2025-01-13

Completion Date

2028-06

Last Updated

2026-02-11

Healthy Volunteers

No

Interventions

BIOLOGICAL

BNT317 DL1

Intravenous infusion

BIOLOGICAL

BNT317 DL2

Intravenous infusion

BIOLOGICAL

BNT317 DL3

Intravenous infusion

BIOLOGICAL

BNT317 DL4

Intravenous infusion

BIOLOGICAL

BNT317 DL5 (intermediate)

Intravenous infusion

BIOLOGICAL

BNT317 DL6 (intermediate)

Intravenous infusion

BIOLOGICAL

BNT317 DL7 (additional)

Intravenous infusion

Locations (11)

Norton Cancer Institute PARENT

Louisville, Kentucky, United States

START Midwest

Grand Rapids, Michigan, United States

Carolina BioOncology Institute, LLC

Huntersville, North Carolina, United States

Rhode Island Hospital

East Providence, Rhode Island, United States

MUSC Hollings Cancer Center

Charleston, South Carolina, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

South Texas Accelerated Research Therapeutics (START), LLC

San Antonio, Texas, United States

Tasman Oncology Research Ltd

Southport, Queensland, Australia

Cancer Research SA

Adelaide, Australia

Monash Medical Centre Clayton

Clayton, Australia

Scientia Clinical Research

Randwick, Australia