Safety and Preliminary Efficacy of BNT314 With or Without an Immune Checkpoint Inhibitor in Cancer Patients With Malignant Solid Tumors

Advanced Malignant Solid Tumor Clinical Trial

Official title: A First-in-Human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate the Safety and Preliminary Efficacy of BNT314 in Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Patients With Advanced Malignant Solid Tumors

Status Recruiting

Clinical Trial Summary

The purpose of this first-in-human study is to find out if BNT314 is safe when it is used alone and when it is used together with another antibody cancer drug (pembrolizumab) in patients with different types of cancer. Patients will receive either BNT314 alone or BNT314 combined with pembrolizumab.

Phase 1 of the study consists of a dose escalation part, and a safety run-in (SRI) and expansion part:

Dose escalation: In this part of the study, 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 (MTD) which is the highest dose with acceptable safety and manageable side effects, or the maximum administered dose (MAD) will be investigated. At the end of this part, the Recommended Phase 2 Dose (RP2D) which is the dose to be tested in Phase 2 will be decided.

Safety Run-In: In this part of the study, BNT314 will be combined with pembrolizumab. Before starting the expansion part, the combination will be tested in another small group of participants (12-28) to find out how safe this combination is.

Expansion: In this part of the study, BNT314 will be combined with pembrolizumab. After the SRI is completed, the study will continue with the expansion part where up to 199 participants with different types of cancer will be included.

The Phase 2 part of the study will be introduced via an amendment to the study protocol.

Clinical Trial 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 (PD), and immunogenicity of BNT314.

In the dose escalation part of the study, patients will periodically receive one infusion of BNT314. In the combination therapy SRI and expansion part, BNT314 will be combined with pembrolizumab and administered intravenously in periodic cycles to patients with selected cancer indications.

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.

For the combination therapy, the maximum treatment period will be 2 years. The maximum study duration is 3 years after the last participant's first treatment in the study. ;

Related Conditions & MeSH terms

• Advanced Malignant Solid Tumor
• Neoplasms

• NCT number: NCT06150183
• Study type: Interventional
• Source: BioNTech SE
• Contact: BioNTech clinical trials patient information
• Phone: +49 6131 9084
• Email: patients@biontech.de
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 30, 2023
• Completion date: February 2030