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

NCT06750185 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-02-11

No results posted yet for this 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

  • Advanced Solid Tumor

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

Sponsors & Collaborators

Principal Investigators

  • BioNTech Responsible Person · BioNTech SE

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-13
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06750185 on ClinicalTrials.gov