Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer

Summary

This first-in-human (FIH) study for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with approved medicinal products and/or in combination with investigational medicinal products (IMPs) including, but not limited to, cemiplimab, docetaxel, carboplatin, paclitaxel, osimertinib, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs), rearranged during transfection (RET) TKIs, BNT316 (an anti-cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\] antibody), an anti-B7-H3 antibody conjugated to a topoisomerase I inhibitor, an anti-human epidermal growth factor receptor 3 (HER3) antibody conjugated to a topoisomerase I inhibitor or a bispecific antibody for programmed death ligand 1 (PD-L1) and vascular endothelial growth factor A (VEGF-A) in participants with non-small cell lung cancer (NSCLC).

The study will comprise several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above.

The study will enroll participants with NSCLC in advanced or metastatic stage in Cohorts 1 to 4 and Cohorts 7 to 10, unresectable NSCLC Stage III in Cohorts 5 and 11, resectable NSCLC of Stage II and III in Cohort 6, advanced/metastatic epidermal growth factor receptor (EGFR)-mutant NSCLC in Cohort EGFR, and advanced/metastatic ALK rearranged or RET rearranged NSCLC in Cohort ALK/RET.

Cohort EGFR and Cohort ALK/RET will enroll only at selected sites in the US.

Conditions

• Non-Small Cell Lung Cancer

Interventions

BIOLOGICAL

BNT116

Intravenous injection

BIOLOGICAL

Cemiplimab

Intravenous infusion

DRUG

Docetaxel

Intravenous infusion

DRUG

Carboplatin

Intravenous infusion

DRUG

Paclitaxel

Intravenous infusion

BIOLOGICAL

BNT316

Intravenous infusion

BIOLOGICAL

anti-B7-H3 antibody conjugated to topoisomerase I inhibitor

Intravenous infusion

BIOLOGICAL

anti-HER3 antibody conjugated to topoisomerase I inhibitor

Intravenous infusion

BIOLOGICAL

Bispecific antibody for PD-L1 and VEGF-A

Intravenous infusion

BIOLOGICAL

Osimertinib

Oral

BIOLOGICAL

ALK-inhibitor or RET-inhibitor

Oral

Sponsors & Collaborators

• BioNTech SE

  lead INDUSTRY

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

2022-06-17

Primary Completion

2030-02-28

Completion

2031-11-30

FDA Drug

Yes

Countries

• United States
• Australia
• Germany
• Hungary
• Poland
• Spain
• Turkey (Türkiye)
• United Kingdom

Study Locations