Clinical trials: sponsored by 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
Genital Herpes Simplex Type 2
A Clinical Trial in Healthy Volunteers and Volunteers With Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions
This exploratory trial will have three parts. Part A is a dose escalation part, Part B is an expanded safety and dose evaluation part, and Part C is a safety and immunogenicity evaluation part in individuals with recurrent HSV-2…
- Trial name
- NCT05432583
- Testing
- BNT163
- Where
- 6 sites in United States
- Volunteers
- 318 people, healthy volunteers welcome
- 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
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
- 217 sites in United States, Argentina and 17 more
- Volunteers
- 558 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
COVID-19, SARS-COV-2 Infection
A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age
This study is designed to find out how well the COVID-19 vaccine protects people 50 to 64, who don't have any serious health problems, compared to a group that receives a vaccine that doesn't contain an ingredient to protect…
- Trial name
- NCT07300839
- Testing
- BNT162b2 Vaccine
- Where
- 196 sites in United States
- Volunteers
- 5,240 people, healthy volunteers welcome
- 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
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
- 365 sites in United States, Argentina and 20 more
- Volunteers
- 1,580 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
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
Unresectable Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer
A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1
An open-label, controlled, multi-site, interventional, 2-arm, Phase II/III trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or…
- Conditions
- Unresectable Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer
- Trial name
- AHEAD-MERIT (NCT04534205)
- Testing
- BNT113, Pembrolizumab
- Where
- 138 sites in United States, Argentina and 19 more
- Volunteers
- 358 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
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
Colorectal Cancer Stage II, Colorectal Cancer Stage III
A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer
This is a multi-site, open-label, Phase II, randomized, trial to compare the efficacy of RO7198457 versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage II/III rectal cancer…
- Trial name
- NCT04486378
- Testing
- RO7198457 intravenous (IV), Observational group (no intervention)
- Where
- 85 sites in United States, Belgium and 5 more
- Volunteers
- 327 people
- Sponsor
- BioNTech SE
Bacterial Vaginosis
A First-in-human Safety Trial of BNT331 Administered as Single Ascending Doses in Healthy Women and as Multiple Ascending Doses in Women Diagnosed With Bacterial Vaginosis
This was a two-part, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy (for Part B) of BNT331 in healthy women (Part A) and in women diagnosed…
- Trial name
- NCT06469164
- Testing
- BNT331
- Where
- 6 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- 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 Malignant Solid Tumor
Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid Tumors
The purpose of this first-in-human study is to find out if BNT314 is safe when it is used alone in patients with different types of cancer.
- Trial name
- NCT06150183
- Testing
- BNT314
- Where
- 14 sites in United States, Belgium and 4 more
- Volunteers
- 41 people
- Sponsor
- BioNTech SE
Monkeypox
A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines
This was a dose-escalation, Phase I/II study evaluating the safety, tolerability, reactogenicity and immunogenicity of the investigational RNA-based multivalent vaccine candidate BNT166a for active immunization against monkeypox…
- Trial name
- NCT05988203
- Testing
- BNT166a
- Where
- 9 sites in United States, United Kingdom
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- BioNTech SE