Clinical trials: sponsored by BioNTech SE
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
SCLC
A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study to evaluate the efficacy and safety of PM8002 in combination with etoposide and platinum in first-line treatment of extensive-stage small cell lung cancer
- Trial name
- NCT05844150
- Testing
- PM8002, Platinum, Etoposide
- Where
- 17 sites in China
- Volunteers
- 50 people
- Sponsor
- Biotheus Inc.
TNBC
A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC
Here, the investigators present the results from a Phase Ib/II study of PM8002 in combination with nab-paclitaxel in subjects with locally advanced or metastatic triple negative breast cancer without previous systematic treatment.
- Trial name
- NCT05918133
- Testing
- PM8002, nab-paclitaxel
- Where
- 8 sites in China
- Volunteers
- 42 people
- Sponsor
- Biotheus Inc.
Pancreatic Cancer, Tumors That Express CA19-9
Study of a New Technique for Imaging Pancreatic Cancer
The purpose of this study is to see how well the experimental imaging agent 89Zr-DFO-HuMab-5B1 attaches to pancreatic tumors, and to find out whether PET/CT scans done with this imaging agent produce better images of cancer.
- Trial name
- NCT04883775
- Testing
- MVT-2163, MVT-5873
- Where
- 7 sites in United States
- Volunteers
- 4 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Pancreatic Cancer
Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies
Phase 1 Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies.
- Trial name
- NCT02672917
- Testing
- MVT-5873, modified FOLFIRINOX (mFOLFIRINOX), gemcitabine + nab-paclitaxel
- Where
- 5 sites in United States
- Volunteers
- 118 people
- Sponsor
- BioNTech Research & Development, Inc.
SCLC
A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with paclitaxel as second line treatment for SCLC.
- Trial name
- NCT05879068
- Testing
- PM8002, Paclitaxel
- Where
- 11 sites in China
- Volunteers
- 99 people
- Sponsor
- Biotheus Inc.
HCC, Liver Cancer
A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC
This study to evaluate the preliminary efficacy, safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma.
- Trial name
- NCT06584071
- Testing
- PM8002, PM1009, atezolizumab
- Volunteers
- 140 people
- Sponsor
- Biotheus Inc.
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
Malignant Neoplasm
PM8002 in the Treatment of Patients With Advanced Solid Tumors
This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of PM8002, a PD-L1/VEGF bispecific antibody, as a single agent in adult subjects with…
- Trial name
- NCT05918445
- Testing
- PM8002
- Where
- 48 sites in China
- Volunteers
- 380 people
- Sponsor
- Biotheus Inc.
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
COVID-19
A Study to Learn About Bivalent COVID-19 RNA Vaccine Candidate(s) in Healthy Infants and Children
The purpose of this clinical trial is to learn about the safety and immune responses of the study vaccine (called a bivalent BNT162b2 Omicron containing vaccine) in healthy infants and children.
- Trial name
- NCT05630352
- 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
- Volunteers
- healthy volunteers welcome
- Sponsor
- BioNTech SE
Covid-19, Protection Against COVID-19
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
Originally, the study was planned to include two parts, i.e., Part A and Part B, however Part B was skipped due to changes in the overall clinical development plan.
- Trial name
- NCT04537949
- Testing
- BNT162b3
- Where
- 2 sites in Germany
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2
Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects
This was a phase I, randomized, placebo-controlled, observer-blind study, for evaluation of safety and immunogenicity of SARS-CoV-2 mRNA vaccine (BNT162b1) in Chinese healthy population.
- Trial name
- NCT04523571
- Testing
- BNT162b1
- Where
- China
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- BioNTech SE