Clinical trials: sponsored by BioNTech SE
Solid Tumor, Adult
Study of Safety and Antitumor Activity of GEN1056 in Participants With Advanced Solid Tumors
The main purpose of this first-in-human study of GEN1056, is to evaluate safety. In addition, the study will determine the recommended dose and frequency for subsequent clinical studies and will assess the preliminary anti-tumor…
- Trial name
- NCT05586321
- Testing
- GEN1056
- Where
- 7 sites in Georgia, Moldova and 1 more
- Volunteers
- 26 people
- Sponsor
- Genmab
SARS-CoV-2 Infection, COVID-19
To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.
Substudy A: The study will evaluate the safety, tolerability, and efficacy of a booster dose of BNT162b2 when administered to participants having previously received 2 doses of BNT162b2 at least 6 months prior to randomization.
- Trial name
- NCT04955626
- Testing
- BNT162b2, BNT162b2 OMI, Combination BNT162b2 and BNT162b2 OMI
- Where
- 154 sites in United States, Brazil and 3 more
- Volunteers
- 16,372 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Pancreatic Cancer
Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma
This study was designed as a Phase 1/randomized Phase 2 open-label study of modified(m) FOLFIRINOX ± BNT321 for adjuvant therapy in pancreatic ductal adenocarcinoma (PDAC) patients post R0 or R1 resection.
- Trial name
- NCT06069778
- Testing
- BNT321 0.5 mg/kg, BNT321 DL 2, mFOLFIRINOX
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals
The purpose of this clinical trial is to learn about the safety, tolerability and immunogenicity of BNT162b RNA-based SARS-CoV-2 vaccine candidates in adults to prevent COVID-19.
- Trial name
- NCT05472038
- Testing
- BNT162b5 Bivalent (WT/OMI BA.2), BNT162b2 Bivalent (WT/OMI BA.1), BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
- Where
- 31 sites in United States
- Volunteers
- 1,453 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Solid Tumor
Dose Escalation Trial of BNT152+153 in Patients With Cancer
This is an open-label, multisite Phase I dose escalation, safety, pharmacokinetics (PK) and pharmacodynamics (PD) trial of BNT152+153 in various solid tumor indications.
- Trial name
- NCT04710043
- Testing
- BNT152, BNT153
- Where
- 7 sites in United States, Czechia
- Volunteers
- 86 people
- Sponsor
- BioNTech SE
Malaria
Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
This first-in-human clinical trial, was a dose escalation multi-center trial designed to assess the safety, tolerability, and immunogenicity of the vaccine component, BNT165b1, a ribonucleic acid (RNA)-lipid nanoparticle (LNP)…
- Trial name
- NCT05581641
- Testing
- BNT165b1
- Where
- 5 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Influenza, Human, COVID-19
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza
Substudy A: This is a Phase 1 randomized, open-label study to describe the safety and immunogenicity of up to 3 dose- level combinations of modRNA quadrivalent influenza vaccine (qIRV (22/23)) and bivalent BNT162b2 (original/Omi…
- Trial name
- NCT05596734
- Testing
- bivalent BNT162b2 (original/Omi BA.4/BA.5), qIRV (22/23), QIV
- Where
- 59 sites in United States
- Volunteers
- 1,019 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Solid Tumor
BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors
This was an open-label, multicenter Phase I/IIa dose escalation, safety, pharmacokinetic and pharmacodynamic (PD) study of BNT151 with expansion cohorts in various solid tumor indications.
- Trial name
- NCT04455620
- Testing
- BNT151
- Where
- 6 sites in United States, Spain
- Volunteers
- 49 people
- Sponsor
- BioNTech SE
Testicular Germ Cell Tumor, Extragonadal Germ Cell Tumor
A Clinical Study Investigating the Therapeutic Effects and Safety of an Investigational Cell Therapy Given With and Without an Additional Investigational Product in Males With Testicular Cancer or a Form of Cancer That Developed From Sperm
This study is designed to evaluate the safety, efficacy, cellular kinetics, and immunogenicity of Claudin 6 (CLDN6) Chimeric antigen receptor T cell (CAR-T) ± CLDN6 ribonucleic acid-lipoplex (RNA-LPX) in participants born male…
- Trial name
- AVENTURINE (NCT06940804)
- Testing
- CLDN6 CAR-T, CLDN6 RNA-LPX
- Sponsor
- BioNTech SE
Solid Tumor, Adult
A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy
The drug that will be investigated in the study is GEN1053. GEN1053 is an antibody designed to (re)activate and increase antitumor immunity.
- Trial name
- NCT05435339
- Testing
- GEN1053
- Where
- 5 sites in United States, Spain
- Volunteers
- 31 people
- Sponsor
- Genmab
Prostate Cancer
PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)
Open-label, multicenter, dose titration and four-arm expansion trial to evaluate the safety, tolerability, immunogenicity, and preliminary efficacy of BNT112 cancer vaccine (BNT112) monotherapy or in combination with cemiplimab…
- Trial name
- PRO-MERIT (NCT04382898)
- Testing
- BNT112, Cemiplimab
- Where
- 22 sites in United States, Germany and 2 more
- Volunteers
- 75 people
- Sponsor
- BioNTech SE
Solid Tumor, Extensive-stage Small Cell Lung Cancer
Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411
This first-in-human (FIH) trial aimed to establish a safe dose of BNT411 as a monotherapy and in combination with atezolizumab, carboplatin and etoposide.
- Trial name
- NCT04101357
- Testing
- BNT411, Atezolizumab, Carboplatin
- Where
- 12 sites in United States, Germany and 2 more
- Volunteers
- 54 people
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older
Results will be submitted, however please note that data are not yet available for all serology outcome measures. This will be a Phase 2/3, randomized, placebo-controlled, observer-blind study evaluating the safety, tolerability…
- Conditions
- SARS-CoV-2 Infection, COVID-19, Maternal Immunization
- Trial name
- NCT04754594
- Testing
- BNT162b2
- Where
- 90 sites in United States, Brazil and 3 more
- Volunteers
- 726 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
Safety and Immunogenicity of RNA-based Vaccines Against SARS-CoV-2 Variants in Healthy Participants
This trial consisted of three parts, Part A, Part B, and Part C, and evaluated the safety and immunogenicity of a third (booster) injection of the multivalent vaccine BNT162b2 (B.1.1.7 + B.1.617.2), and the safety and…
- Conditions
- SARS-CoV-2 Infection, COVID-19, SARS-CoV-2 Acute Respiratory Disease, SARS (Disease)
- Trial name
- NCT05004181
- Testing
- BNT162b2, Multivalent BNT162b2 (B.1.1.7 + B.1.617.2), Monovalent BNT162b2 (B.1.1.7)
- Where
- 35 sites in United States, Germany and 2 more
- Volunteers
- 1,380 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID19
Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years
This is a 4 dose study with 124 participants (7 adults ,117 children). Adults are considered to be participants 18 years of age or older. Participants are going to be enrolled based on conditions that make them immunocompromised.
- Trial name
- NCT04895982
- Testing
- BNT162b2
- Where
- 29 sites in United States, Brazil and 2 more
- Volunteers
- 124 people
- Sponsor
- BioNTech SE
Solid Tumor, Gastric Cancer
Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors
This study was planned as an open-label, multi-site, Phase I/IIa dose escalation, safety, and pharmacokinetic (PK) trial of BNT141 followed by expansion cohorts in patients with Claudin 18.2 (CLDN18.2)-positive tumors.
- Conditions
- Solid Tumor, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma
- Trial name
- NCT04683939
- Testing
- BNT141, Nab-paclitaxel, Gemcitabine
- Where
- 7 sites in United States, Canada
- Volunteers
- 13 people
- Sponsor
- BioNTech SE
COVID-19, SARS-CoV-2 Infection
A Trial Investigating the Safety and Effects of One or Two Additional Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 or BNT162-04 Trial Subjects
Trial to evaluate the safety and immunogenicity of one or two boosting doses of Comirnaty or one dose of BNT162b2s01 (Variant of concern [VOC] strain B.1.351) in BNT162-01 trial participants, or two boosting doses of Comirnaty in…
- Trial name
- NCT04949490
- Testing
- BNT162b2s01, BNT162b2
- Where
- 4 sites in Germany
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Infections, Respiratory, Virus Diseases
A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-19 in Healthy and Immunocompromised Adults
Originally, the study was planned to include two parts, i.e., Part A and Part B, however Part B was cancelled due to changes in the overall clinical development plan.
- Conditions
- Infections, Respiratory, Virus Diseases, Infection Viral, Vaccine Adverse Reaction
- Trial name
- NCT04380701
- Testing
- BNT162a1, BNT162b1, BNT162b2
- Where
- 5 sites in Germany
- Volunteers
- 512 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age
This study will assess the safety and immunogenicity of a fourth dose (booster) of BNT162b2 when coadministered with SIIV compared to separate administration of the vaccines when given 1 month apart (SIIV followed by BNT162b2)…
- Trial name
- NCT05310084
- Testing
- BNT162b2, Seasonal Inactivated Influenza Vaccine
- Where
- 26 sites in Australia, New Zealand
- Volunteers
- 1,134 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Advanced Endometrial Cancer
GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer
The goal of this clinical study is to learn about the bispecific antibody, acasunlimab (also known as GEN1046) in combination with the cancer drug pembrolizumab for treatment of participants with incurable endometrial cancer…
- Trial name
- NCT06046274
- Testing
- Pembrolizumab, Acasunlimab
- Where
- 29 sites in United States, Belgium and 4 more
- Sponsor
- Genmab