Clinical trials: sponsored by BioNTech SE
Advanced Solid Tumor
A Study of PM1015 in Patients With Advanced Solid Tumors
PM1015 is a specific antibody targeting CD73. This is a phase I study to evaluate the efficacy and safety of PM1015 in patients with advanced solid tumor.
- Trial name
- NCT05950815
- Testing
- CD73 Antigen
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Biotheus Inc.
Ovarian Cancer
Ovarian Cancer Treatment With a Liposome Formulated mRNA Vaccine in Combination With (Neo-)Adjuvant Chemotherapy
This is a first-in-human, open label phase I study in ovarian cancer patients with primary disease eligible for standard-of-care treatment with neo-adjuvant chemotherapy, i.e.
- Trial name
- OLIVIA (NCT04163094)
- Testing
- W_ova1 Vaccine
- Where
- Netherlands
- Volunteers
- 8 people
- Sponsor
- University Medical Center Groningen
Advanced Tumors
A Study of PM1022 in Patients With Advanced Tumors
This study incluces a phase I study to evaluate the tolerance, safety, pharmacokinetic characteristics and preliminary efficacy of PM1022 in patients with advanced tumors and a phase IIa study to investigate the efficacy of…
- Trial name
- NCT05867771
- Testing
- PM1022
- Where
- 2 sites in China
- Volunteers
- 200 people
- Sponsor
- Biotheus Inc.
Advanced Solid Tumors
Clinical Study of PM1003 in Phase I/IIa Treatment of Advanced Malignant Solid Tumors
This is a single-arm, open-lable, multicenter phase I/IIa clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of PM1003 in the treatment of advanced solid tumors.
- Trial name
- NCT05862831
- Testing
- PM1003 Injection
- Where
- 2 sites in China
- Volunteers
- 285 people
- Sponsor
- Biotheus Inc.
Advanced Tumor
Phase I/IIa Study for PM1032 in the Treatment of Patients With Advanced Solid Tumors
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of PM1032 for patients with advanced tumors, also to explore the recommended Phase Ⅱ Dose（RP2D） of PM1032.
- Trial name
- NCT05839106
- Testing
- PM1032 injection
- Where
- 3 sites in China
- Volunteers
- 200 people
- Sponsor
- Biotheus Inc.
Pancreatic Carcinoma, Tumors That Express CA 19-9
Study of 177Lu Human Monoclonal Antibody 5B1 (MVT-1075) in Combination With a Blocking Dose of MVT-5873 as Radioimmunotherapy
Open label, nonrandomized, dose-escalation with cohort expansion study of MVT-5873/MVT-1075 in subjects with previously treated, Carbohydrate Antigen 19-9 (CA19-9) positive malignancies (e.g., pancreatic adenocarcinoma).
- Trial name
- NCT03118349
- Testing
- MVT-1075, MVT-5873
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- BioNTech Research & Development, Inc.
Advanced Tumor
A Study of PM1009 (Anti-TIGIT/PVRIG) in Patients With Advanced Tumours
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of PM1009 for patients with advanced tumors, also to explore the recommended Phase Ⅱ Dose（RP2D） of PM1009.
- Trial name
- NCT05607563
- Testing
- PM1009 injection
- Where
- China
- Volunteers
- 54 people
- Sponsor
- Biotheus Inc.
Advanced Solid Tumours
A Study of PM1021 (Anti-TIGIT) With or Without PM8001 (Anti-PD-L1/TGF-β) in Patients With Advanced Solid Tumours
The purpose of this research is to assess the safety, tolerability and effectiveness of PM1021 Monotherapy and PM1021 in Combination with PM8001 in Patients with Advanced Solid Tumours.
- Trial name
- NCT05537051
- Testing
- PM1021, PM8001
- Volunteers
- 30 people
- Sponsor
- Biotheus Inc.
SARS-CoV-2 Infection, COVID-19
Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults
This is a Phase 1/2, randomized, placebo-controlled, and observer-blind study in healthy Japanese adults. The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against…
- Trial name
- NCT04588480
- Testing
- BNT162b2
- Where
- 2 sites in Japan
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults
This study will compare the safety and tolerability of lyophilized BNT162b2 presented in single dose vials to those of frozen-liquid BNT162b2 in multidose vials and determine whether the immune response is noninferior.
- Trial name
- NCT04816669
- Testing
- BNT162b2
- Where
- 21 sites in United States
- Volunteers
- 629 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants
This is a Phase 3, randomized, observer-blind study in healthy individuals. The primary study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate (BNT162b2): As a 30-microgram dose…
- Trial name
- NCT04713553
- Testing
- BNT162b2, BNT162b2.B.1.351
- Where
- 17 sites in United States
- Volunteers
- 1,574 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Pancreatic Carcinoma, Tumors That Express CA19-9
Phase 1 Imaging Study of 89Zr-DFO-HuMab-5B1 With HuMab-5B1
Open label, nonrandomized, dose-escalation trial of MVT-2163 and MVT-5873 used in performing PET scans. The study is designed to determine the best time and dose of these agents that result in the best PET image of a tumor.
- Trial name
- NCT02687230
- Testing
- MVT-2163, MVT-5873
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- BioNTech Research & Development, Inc.
Carcinoma, Non-Small-Cell Lung, Lung Cancer
A Personal Cancer Vaccine (NEO-PV-01) With Pembrolizumab and Chemotherapy for Patients With Lung Cancer
The purpose of this study is to find out if treatment with NEO-PV-01 in combination with pembrolizumab and chemotherapy (pembrolizumab/chemotherapy) is safe and useful for patients with lung cancer.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Lung Cancer, Nonsquamous Nonsmall Cell Neoplasm of Lung
- Trial name
- NCT03380871
- Testing
- NEO-PV-01, Pembrolizumab, Adjuvant
- Where
- 5 sites in United States
- Volunteers
- 38 people
- Sponsor
- BioNTech US Inc.
Urinary Bladder Cancer, Bladder Tumors
A Personal Cancer Vaccine (NEO-PV-01) w/ Nivolumab for Patients With Melanoma, Lung Cancer or Bladder Cancer
The purpose of this study is to evaluate if the treatment with NEO-PV-01 + adjuvant in combination with nivolumab is safe and useful for patients with certain types of cancer.
- Conditions
- Urinary Bladder Cancer, Bladder Tumors, Transitional Cell Carcinoma of the Bladder, Malignant Melanoma
- Trial name
- NCT02897765
- Testing
- NEO-PV-01, Nivolumab, Adjuvant
- Where
- 9 sites in United States
- Volunteers
- 34 people
- Sponsor
- BioNTech US Inc.
Metastatic Melanoma
A Personal Cancer Vaccine (NEO-PV-01) and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma
The primary purpose of this study is to demonstrate that the NEO-PV-01 vaccine, either with APX005M or ipilimumab, and nivolumab is safe for the treatment of patients with advanced or metastatic melanoma.
- Trial name
- NCT03597282
- Testing
- NEO-PV-01, Nivolumab, Adjuvant
- Where
- 8 sites in United States
- Volunteers
- 22 people
- Sponsor
- BioNTech US Inc.
Melanoma
RBL001/RBL002 Phase I Clinical Trial
Clinical first-in-human dose escalation study evaluating the safety and tolerability of intranodal administration of an RNA-based cancer vaccine targeting two tumor-associated antigens in patients with advanced melanoma
- Trial name
- MERIT (NCT01684241)
- Testing
- RBL001/RBL002
- Where
- 4 sites in Austria, Germany
- Volunteers
- 29 people
- Sponsor
- BioNTech RNA Pharmaceuticals GmbH
Melanoma
IVAC MUTANOME Phase I Clinical Trial
Clinical first-in-human study evaluating the safety, tolerability and immunogenicity of intra-nodal administration of a personalized vaccination with IVAC MUTANOME vaccine with or without initial treatment with RBL001/RBL002…
- Trial name
- NCT02035956
- Testing
- IVAC MUTANOME, RBL001/RBL002
- Where
- 3 sites in Austria, Germany
- Volunteers
- 15 people
- Sponsor
- BioNTech RNA Pharmaceuticals GmbH
Glioblastoma
GAPVAC Phase I Trial in Newly Diagnosed Glioblastoma Patients
The primary objective of this study is to assess the safety and tolerability, feasibility and biological activity (immunogenicity) of the actively personalized vaccination (APVAC) concept in newly diagnosed glioblastoma (GB)…
- Trial name
- NCT02149225
- Testing
- APVAC1 vaccine plus Poly-ICLC and GM-CSF, APVAC2 vaccine plus Poly-ICLC and GM-CSF
- Where
- 6 sites in Denmark, Germany and 3 more
- Volunteers
- 16 people
- Sponsor
- Immatics Biotechnologies GmbH