Antineoplastic Agents

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Pembrolizumab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Escalating dose levels and backfill cohorts

The BNT314 starting dose for the SRI combination therapy will be one DL lower than the RP2D/MTD/maximum administered dose (MAD) determined from the monotherapy dose escalation.

BNT314

BioNTech clinical trials patient information

BioNTech Responsible Person

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.

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.

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

Reported with number and proportion of patients with a confirmed complete response (CR) or partial response (PR) as best overall response.

Reported with number and proportion of patients with a CR, PR, or stable disease (SD) (assessed at least 6 weeks after first dose of study treatment) as best overall response.

Reported with number and proportion of patients with a confirmed CR or PR as best overall response.

DOR is defined as the time from first objective response (CR or PR) to first occurrence of objective tumor progression or death from any cause, whichever occurs first.

Reported with number and proportion of patients with a CR, PR, or SD (assessed at least 6 weeks after first dose of study treatment) as best overall response.

Defined as time from first dose of study treatment to first confirmed disease progression or death from any cause, whichever occurs first.

Defined as the time from first dose of study treatment to death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety and Preliminary Efficacy of BNT314 With or Without an Immune Checkpoint Inhibitor in Cancer Patients With Malignant Solid Tumors	NCT06150183	Advanced Malign...	BNT314 Pembrolizumab	18 Years -	BioNTech SE
Safety and Preliminary Efficacy of BNT314 With or Without an Immune Checkpoint Inhibitor in Cancer Patients With Malignant Solid Tumors	NCT06150183	Advanced Malign...	BNT314 Pembrolizumab	18 Years -	BioNTech SE

Spots Global Cancer Trial Database for bnt314

Every month we try and update this database with for bnt314 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bnt314

Every month we try and update this database with for bnt314 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bnt314 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.