Clinical trials: sponsored by BioNTech SE
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
This is a Phase II, multi-site, open-label, parallel group study in participants with untreated extended-stage small-cell lung cancer (ES-SCLC) (Cohort 1) or small-cell lung cancer (SCLC) which has progressed on first- or…
- Trial name
- NCT06449209
- Testing
- BNT327 Dose Level 1 (DL1), BNT327 Dose Level 2 (DL2), Etoposide
- Where
- 64 sites in United States, Australia and 3 more
- Volunteers
- 110 people
- Sponsor
- BioNTech SE
Advanced Solid Tumor
Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors
This is a first-in-human (FIH), open-label, multi-site study which will evaluate the safety, efficacy, tolerability, pharmacokinetics (PK), and immunogenicity of increasing doses of BNT317 in participants with advanced solid…
- Trial name
- NCT06750185
- Testing
- BNT317 DL1, BNT317 DL2, BNT317 DL3
- Where
- 11 sites in United States, Australia
- Volunteers
- 248 people
- Sponsor
- BioNTech SE
HIV -1 Infection
A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV
This study will test the safety and blood levels of the antibody BNT351 in people living without and with human immunodeficiency virus (HIV).
- Trial name
- NCT07392372
- Testing
- BNT351
- Where
- 6 sites in United States, Germany
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Malaria
A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
This was a randomized, dose-escalation Phase I/IIa study to evaluate safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P.
- Trial name
- NCT06069544
- Testing
- BNT165c, BNT165d
- Where
- 5 sites in United States
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- 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
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
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
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
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
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
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
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
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
Advanced Solid Tumor
A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors
The aim of this first-in-human (FIH) open-label, multi-site study is to evaluate safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary clinical efficacy of BNT3212, including identification of the…
- Trial name
- NCT07147348
- Testing
- BNT3212, Pumitamig
- Where
- 17 sites in Australia, China
- Volunteers
- 375 people
- Sponsor
- BioNTech SE
COVID-19, SARS-COV-2 Infection
A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Participants Ages 12 Through 64 Years Considered at Higher Risk of Severe COVID-19, and Participants Ages ≥65 Years
The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19.
- Trial name
- NCT07069309
- Testing
- BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)
- Where
- 19 sites in United States
- Volunteers
- 774 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children
This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and…
- Trial name
- NCT04816643
- Testing
- Biological/Vaccine: BNT162b2 10mcg, BNT162b2 20mcg, BNT162b2 30mcg
- Where
- 128 sites in United States, Brazil and 4 more
- Volunteers
- 11,837 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Colorectal Cancer Stage II, Colorectal Cancer Stage III
Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant Chemotherapy
This is a multi-site epidemiological study designed to monitor circulating tumor DNA (ctDNA) status in participants with Stage II (high risk)/III colorectal cancer (CRC) following resection/prior to adjuvant chemotherapy (AdCTx)…
- Trial name
- NCT04813627
- Testing
- Regular blood sample collection for ctDNA assessment
- Where
- 74 sites in United States, Belgium and 2 more
- Volunteers
- 2,079 people
- Sponsor
- BioNTech SE
Recurrent Glioblastoma
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma
This multi-site Phase II study will enroll adults with histologically confirmed diagnosis of World Health Organization (WHO) Grade IV glioblastoma (GBM), isocitrate dehydrogenase (IDH)-wildtype consistent with WHO central nervous…
- Trial name
- NCT07297212
- Testing
- Pumitamig, Bevacizumab, Temozolomide
- Where
- 6 sites in China
- Volunteers
- 75 people
- Sponsor
- BioNTech SE