Clinical trials: sponsored by BioNTech SE
Advanced Lung Cancer
A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer
This study aims to investigate the combination of BNT324, a B7-H3 antibody-drug conjugate (ADC) with BNT327, a programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF) bispecific antibody, in participants…
- Trial name
- NCT06892548
- Testing
- BNT324, BNT327
- Where
- 91 sites in United States, Australia and 8 more
- Volunteers
- 594 people
- Sponsor
- BioNTech SE
Influenza,Human, COVID-19
A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People
This study is to learn about flu and COVID vaccines, either alone or when mixed together. Healthy people aged 18 or older can join. Participants will get one shot in each arm, either a flu or COVID vaccine, alone or mixed.
- Trial name
- NCT06683352
- Testing
- Investigational Influenza Vaccine, COVID-19 Vaccine, Investigational Influenza/COVID-19 Vaccine
- Where
- 22 sites in United States
- Volunteers
- 1,353 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Non Small Cell Lung Cancer
ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
The goal of this Phase 3 clinical trial is to study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on…
- Trial name
- PRESERVE-003 (NCT05671510)
- Testing
- Gotistobart, Docetaxel
- Where
- 152 sites in United States, Australia and 10 more
- Volunteers
- 630 people
- Sponsor
- OncoC4, Inc.
Advanced Solid Tumor Cancer
Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors
This study is the first time the drug BNT3214 (also referred to as PM8102) will be tested in people. It is designed to find out if the drug is safe and how well it works for adults with advanced solid tumors.
- Trial name
- NCT07455734
- Testing
- BNT3214
- Where
- 16 sites in Australia, China and 2 more
- Volunteers
- 533 people
- Sponsor
- BioNTech SE
Non-CNS Tumor
A Safety and Antitumor Activity Trial of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors
The main purpose is to assess the safety and clinical activity of GEN1042 in combination with radiotherapy or GEN1042 in combination with radiotherapy and pembrolizumab as a treatment option for participants with metastatic solid…
- Trial name
- NCT05491317
- Testing
- GEN1042, Pembrolizumab, Radiotherapy
- Where
- 2 sites in France
- Volunteers
- 13 people
- Sponsor
- Genmab
Mpox (Monkeypox), Smallpox
A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa
This is a randomized, double-blind, placebo-controlled study which aims to assess the safety, reactogenicity, and immunogenicity after one and two doses of BNT166a or placebo in healthy participants.
- Conditions
- Mpox (Monkeypox), Smallpox, Orthopoxvirus Infection
- Trial name
- NCT07379580
- Testing
- BNT166a
- Where
- 6 sites in Democratic Republic of the Congo, South Africa
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Malignant Solid Tumor
Trial to Assess the Safety and Preliminary Efficacy of GEN1055 on Malignant Solid Tumors as Monotherapy and as Combination Therapy
The goal of this trial is to learn about the antibody GEN1055 when it is used alone and when it is used together with another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of participants with…
- Trial name
- NCT06391775
- Testing
- GEN1055, Pembrolizumab, Standard Chemotherapy
- Where
- 4 sites in United States, Spain
- Volunteers
- 21 people
- Sponsor
- Genmab
COVID-19, SARS-COV-2 Infection
A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That Are Considered at Higher Risk of Severe COVID-19
The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19, called BNT162b2 (2025/2026 formulation).
- Trial name
- NCT07222384
- Testing
- BNT162b2 (2025/2026 formulation)
- Where
- 29 sites in United States, Puerto Rico
- Volunteers
- 344 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
COVID-19 Vaccines
A Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of Age
The purpose of this study is to learn about the safety and effects of an updated COVID-19 vaccine (called BNT162b2) in adults 18 to 64 years of age.
- Trial name
- NCT07730450
- Testing
- BNT162b2 Vaccine, Tdap Vaccine
- Where
- 5 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Muscle-invasive Urothelial Carcinoma
A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-risk Muscle-invasive Urothelial Carcinoma (MIUC)
The original purpose of this study was to evaluate the efficacy of adjuvant treatment with autogene cevumeran plus nivolumab compared with nivolumab in participants with high risk MIUC.
- Trial name
- IMCODE004 (NCT06534983)
- Testing
- Autogene Cevumeran, Nivolumab
- Where
- 43 sites in United States, Argentina and 13 more
- Volunteers
- 62 people
- Sponsor
- Hoffmann-La Roche
SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2
A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children
The purpose of this clinical trial is to learn about the safety, extent of the side effects, and immune responses of the study vaccine (called variant-adapted BNT162b2 RNA-based vaccine) in healthy children.
- Conditions
- SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19
- Trial name
- NCT05543616
- Testing
- Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
- Where
- 96 sites in United States, Brazil and 3 more
- Volunteers
- 4,338 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Malignant Solid Tumor, Non-Small Cell Lung Cancer (NSCLC)
GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors
The goal of this trial is to learn about the antibody GEN1042 when it is used alone and when it is used together with another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of participants with…
- Conditions
- Malignant Solid Tumor, Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Melanoma
- Trial name
- NCT04083599
- Testing
- GEN1042, Pembrolizumab, Cisplatin
- Where
- 76 sites in United States, Denmark and 10 more
- Volunteers
- 350 people
- Sponsor
- Genmab
Triple Negative Breast Cancer(TNBC)
PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC
This multicenter, randomized, double-blind study will evaluate the safety and efficacy of PM8002 in combination with Nab-Paclitaxel compared with placebo combined with Nab-Paclitaxel as first-line treatment in inoperable locally…
- Trial name
- NCT06419621
- Testing
- PM8002, Nab-Paclitaxel
- Where
- 70 sites in China
- Volunteers
- 392 people
- Sponsor
- Biotheus Inc.
Pancreatic Ductal Adenocarcinoma (PDAC)
A Clinical Trial Testing the Safety of Pumitamig (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have Not Been Treated Yet for Pancreatic Cancer
This study will enroll adults with confirmed metastatic pancreatic ductal adenocarcinoma (PDAC, systemic PDAC treatment naïve), Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1, and adequate organ function.
- Trial name
- NCT07255404
- Testing
- Pumitamig, Nab-paclitaxel, Gemcitabine
- Where
- 24 sites in Australia, China
- Volunteers
- 105 people
- Sponsor
- BioNTech SE
CRC (Colorectal Cancer)
PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer
PM8002 (BNT327) is a bispecific antibody targeting PD-L1 and VEGF. This is a phase II trial to evaluate the efficacy and safety of PM8002 in combination with chemotherapy in first line MSS or MSI-L/pMMR metastatic colorectal…
- Trial name
- NCT07133750
- Testing
- PM8002, Chemotherapy Regimen 1, Chemotherapy Regimen 2
- Where
- 11 sites in China
- Volunteers
- 100 people
- Sponsor
- Biotheus Inc.
Non-Small Cell Lung Cancer
Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
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…
- Trial name
- LuCa-MERIT-1 (NCT05142189)
- Testing
- BNT116, Cemiplimab, Docetaxel
- Where
- 45 sites in United States, Australia and 6 more
- Volunteers
- 320 people
- Sponsor
- BioNTech SE
Neuroendocrine Neoplasm
A Study of PM8002 in Combination With Chemotherapy in Patients With NEN
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with FOLFIRI as second line treatment for neuroendocrine neoplasm (NEC and Ki-67≥55% G3 NET).
- Trial name
- NCT05879055
- Testing
- PM8002, FOLFIRI
- Where
- 13 sites in China
- Volunteers
- 31 people
- Sponsor
- Biotheus Inc.
Hepatocellular Carcinoma
PM8002 in Combination With Chemotherapy as First Line Therapy in Hepatocellular Carcinoma
This is a multicenter, single-arm, open-label phase II study to evaluate the efficacy and safety of PM8002 in combination with chemotherapy in the first-line treatment of subjects with inoperable HCC.
- Trial name
- NCT05864105
- Testing
- PM8002, FOLFOX regimen
- Where
- 9 sites in China
- Volunteers
- 35 people
- Sponsor
- Biotheus Inc.
Metastatic Colorectal Cancer
A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment Pumitamig (BNT327) and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer
This randomized, multi-site, three-part study will test a new treatment called BNT314, which is designed to help the body's own defense to fight cancer in combination with another new treatment (pumitamig, which is a cancer…
- Trial name
- NCT07079631
- Testing
- BNT314, Pumitamig, SoC chemotherapy treatment 1
- Where
- 14 sites in United States, Germany and 3 more
- Volunteers
- 482 people
- Sponsor
- BioNTech SE
Locally Advanced Breast Cancer, Triple Negative Breast Cancer
Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy
This study is a Phase II, multi-site, randomized, open-label clinical study to evaluate the safety, efficacy, and pharmacokinetics (PK) of BNT327 at two dose levels in combination with chemotherapeutic agents in the first- and…
- Conditions
- Locally Advanced Breast Cancer, Triple Negative Breast Cancer, Metastatic Triple Negative Breast Cancers
- Trial name
- NCT06449222
- Testing
- BNT327 Dose Level 1 (DL1), BNT327 Dose Level 1 (DL2), Nab-placlitaxel
- Where
- 31 sites in United States, Australia and 2 more
- Volunteers
- 83 people
- Sponsor
- BioNTech SE