NCT06150183

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

A First-in-Human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate the Safety and Preliminary Efficacy of BNT314 as Monotherapy in Patients With Advanced Malignant Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, multinational safety study in patients with metastatic or advanced malignant solid tumors for whom, at the discretion of the investigator, there is no available standard therapy likely to confer clinical benefit, evaluating the safety, tolerability, preliminary antitumor activity, pharmacokinetics (PK), pharmacodynamics, and immunogenicity of BNT314. During dose escalation, BNT314 will be administered to patients via one infusion in periodic cycles. Additional cohorts (backfill cohorts) administering BNT314 as monotherapy will assign patients to specific DLs, based on the emerging safety, PK, and pharmacodynamic data. This would allow for further assessment of dose- and exposure-response relationships for clinical activity, safety, and tolerability to support BNT314 dose optimization. The treatment period will last until progressive disease (PD), confirmed PD (as per immune Response Evaluation Criteria in Solid Tumors \[iRECIST\]), unacceptable toxicity, or withdrawal of consent, whichever happens first. The maximum duration of BNT314 administration in this study is 2 years.

Conditions

• Advanced Malignant Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	BNT314	Intravenous infusion

Timeline

• Start date: 2023-11-30
• Primary completion: 2027-06-01
• Completion: 2028-03-01
• First posted: 2023-11-29
• Last updated: 2026-01-23

Locations

14 sites across 6 countries: United States, Belgium, Denmark, Japan, Spain, United Kingdom

Regulatory

• FDA-regulated drug study