NCT06750185

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will be assigned to one of four dose levels of BNT317. One treatment cycle contains one treatment. Participants may receive investigational medicinal product (IMP) for up to 2 years or until they experience disease progression, unacceptable toxicities, withdrawal of consent, study discontinuation or investigator decision. The total duration of the study for a singe participant may be up to 2 years, plus follow-up until the last participant has completed 1 year of survival follow-up (excluding screening). In the dose escalation phase, an accelerated titration design for Dose Level 1 (DL1) and a Bayesian Optimal Interval (BOIN) design for DL2 to DL4 will be used to evaluate dose limiting toxicities (DLTs) and determine the maximum tolerated dose (MTD). Additional dosing schedules and/or intermediate or higher dose levels may be evaluated based on the available safety, antitumor activity, PK, and pharmacodynamic (PD) data.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-01-13
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2024-12-27
• Last updated: 2026-02-11

Locations

11 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study