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Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid Tumors

NCT06150183 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2026-01-23

No results posted yet for this study

Summary

The purpose of this first-in-human study is to find out if BNT314 is safe when it is used alone in patients with different types of cancer.

This is a dose escalation study in which patients will be assigned to multiple dose levels (DLs) of BNT314 given alone. By escalating the dose with a small group of patients, the Maximum Tolerated Dose which is the highest dose with acceptable safety and manageable side effects, or the maximum administered dose will be investigated.

Conditions

  • Advanced Malignant Solid Tumor

Interventions

BIOLOGICAL

BNT314

Intravenous infusion

Sponsors & Collaborators

  • Genmab

    collaborator INDUSTRY

  • BioNTech SE

    lead INDUSTRY

Principal Investigators

  • BioNTech Responsible Person · BioNTech SE

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2027-06-30
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Denmark
  • Japan
  • Spain
  • United Kingdom

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 NCT06150183 on ClinicalTrials.gov