Clinical trials: open to volunteers, sponsored by BioNTech SE
Non-small Cell Lung Cancer
Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)
This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC).
- Trial name
- NCT06712316
- Testing
- Pumitamig, Pembrolizumab, Carboplatin
- Where
- 366 sites in United States, Argentina and 20 more
- Volunteers
- 1,580 people
- Sponsor
- BioNTech SE
Breast Neoplasms
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
This is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group.
- Trial name
- NCT07173751
- Testing
- Pumitamig, Nab-paclitaxel/Paclitaxel, Gemcitabine
- Where
- 224 sites in United States, Argentina and 17 more
- Volunteers
- 558 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
Advanced Solid Tumors
A First-in-human Clinical Trial to Test if the Investigational Drug BNT3219 is Safe and Potentially Beneficial for People With Advanced Solid Tumors When Given Alone or Together With Other Investigational Drugs
This study will test BNT3219 (also known as PM1092) in adults with advanced solid tumors whose cancer has progressed after available standard treatments.
- Trial name
- NCT07893054
- Testing
- BNT3219
- Volunteers
- 207 people
- Sponsor
- BioNTech SE
Non-small Cell Lung Cancer
A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)
This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with pumitamig (also known as BNT327 or PM8002) in participants with relapsed, progressive as well…
- Trial name
- NCT07111520
- Testing
- BNT326, Pumitamig
- Where
- 86 sites in United States, Australia and 8 more
- Volunteers
- 880 people
- Sponsor
- BioNTech SE
Advanced Solid Tumors
A Clinical Trial to Test if the Investigational Drug BNT3210 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker Sialyl-Tn
This study is the first time BNT3210 will be tested in people. It will evaluate different dose levels to find suitable doses and to understand how safe the treatment is and how it may help people with advanced solid tumors.
- Trial name
- NCT07886684
- Testing
- BNT3210
- Volunteers
- 173 people
- Sponsor
- BioNTech SE
Endometrial Cancer
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
The study is divided into two cohorts (Cohort 1 and Cohort 2), to which participants will be enrolled based on the amount of human epidermal growth factor receptor 2 (HER2) in their tumor sample.
- Trial name
- Fern-EC-01 (NCT06340568)
- Testing
- BNT323/DB-1303, Doxorubicin, Paclitaxel
- Where
- 206 sites in United States, Argentina and 25 more
- Volunteers
- 480 people
- Sponsor
- BioNTech SE
Metastatic Castration-resistant Prostate Cancer
A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer
This study will test whether BNT324 is safe and works better against metastatic castration-resistant prostate cancer (mCRPC) than the current standard of care (SoC) chemotherapy, which is docetaxel (given together with the…
- Trial name
- NCT07365995
- Testing
- BNT324, Docetaxel, Prednisone/prednisolone
- Where
- 52 sites in United States, Australia and 5 more
- Volunteers
- 736 people
- Sponsor
- BioNTech SE
Advanced Solid Cancers
A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9
The main goal of this study is to evaluate the safety of BNT329 and to identify the best dose of BNT329. This will be done by measuring the number of side effects that participants experience and how severe they are.
- Trial name
- NCT07186842
- Testing
- BNT329, CA19-9-targeting monoclonal antibody
- Where
- 18 sites in United States, Australia and 3 more
- Volunteers
- 245 people
- Sponsor
- BioNTech SE
Locally Advanced Breast Cancer, Unresectable Breast Carcinoma
A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer
This is a Phase I/II, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination…
- Conditions
- Locally Advanced Breast Cancer, Unresectable Breast Carcinoma, Metastatic Breast Cancer
- Trial name
- NCT06827236
- Testing
- BNT323, BNT327
- Where
- 81 sites in United States, Australia and 9 more
- Volunteers
- 380 people
- Sponsor
- BioNTech SE
HIV -1 Infection
A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIV
This study will test a new ribonucleic acid (RNA)-based vaccine called BNT168 in adults living both with and without human immunodeficiency virus (HIV), to see how safe it is, how well it triggers the body's immune response and…
- Trial name
- NCT07698600
- Testing
- BNT168
- Where
- 4 sites in United States, South Africa
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Extensive-stage Small-cell Lung Cancer
Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
This is a Phase III, multisite, randomized, double-blinded study to investigate pumitamig (BNT327) combined with chemotherapy (etoposide/carboplatin) compared to atezolizumab combined with chemotherapy (etoposide/carboplatin) for…
- Trial name
- NCT06712355
- Testing
- Pumitamig, Atezolizumab, Etoposide
- Where
- 225 sites in United States, Australia and 12 more
- Volunteers
- 621 people
- Sponsor
- BioNTech SE
Advanced Solid Tumor
A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors
This study will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with immunotherapeutic agents (Part 2) in participants with histologically or…
- Trial name
- NCT07070232
- Testing
- BNT326, Pumitamig, Itraconazole
- Where
- 77 sites in United States, Australia and 7 more
- Volunteers
- 1,438 people
- Sponsor
- BioNTech SE
COVID-19 Vaccines
A Study of COVID-19 Vaccine(s) in Children and Adults
The purpose of this study is to learn about the safety and effects of updated COVID-19 vaccines (called BNT162b2) in participants 5 Through 64 Years of Age with risk factors for Severe COVID-19, and Participants 65 Years of Age…
- Trial name
- NCT07798648
- Testing
- BNT162b2
- Where
- 14 sites in United States
- Volunteers
- 700 people, healthy volunteers welcome
- 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
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
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