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
Untreated, Unresectable, or Metastatic Colorectal Cancer
A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer
The purpose of this study is to evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in combination with chemotherapy in participants with previously untreated, unresectable, or…
- Trial name
- NCT07221357
- Testing
- Pumitamig, FOLFOX, FOLFIRI
- Where
- 286 sites in United States, Argentina and 23 more
- Volunteers
- 990 people
- Sponsor
- Bristol-Myers Squibb
Advanced Renal Cell Carcinoma (RCC)
A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208)
The purpose of this study is to evaluate the safety, tolerability, and efficacy of Pumitamig alone or in combination with other agents in participants with advanced Renal Cell Carcinoma (RCC)
- Trial name
- NCT07293351
- Testing
- Pumitamig, Ipilimumab, Cabozantinib
- Where
- 95 sites in United States, Argentina and 18 more
- Volunteers
- 474 people
- Sponsor
- Bristol-Myers Squibb
Non-Small Cell Lung Cancer (NSCLC)
A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)
The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.
- Trial name
- NCT07361510
- Testing
- Pumitamig, Pembrolizumab
- Where
- 283 sites in United States, Argentina and 34 more
- Volunteers
- 750 people
- Sponsor
- Bristol-Myers Squibb
Hepatocellular Carcinoma (HCC)
A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)
The purpose of this study is to evaluate the safety and tolerability of Pumitamig alone or in combination with Ipilimumab in participants with first-line advanced or unresectable Hepatocellular Carcinoma (HCC)
- Trial name
- NCT07291076
- Testing
- Pumitamig, Ipilimumab
- Where
- 67 sites in United States, Australia and 12 more
- Volunteers
- 198 people
- Sponsor
- Bristol-Myers Squibb
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
SCLC
PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer
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
- NCT06616532
- Testing
- PM8002, Paclitaxel, Topotecan
- Where
- 45 sites in China
- Volunteers
- 404 people
- Sponsor
- Biotheus Inc.
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
Advanced Solid Tumors
A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1311/BNT324 in subjects with advanced solid tumors.
- Trial name
- NCT05914116
- Testing
- DB-1311, Lopinavir and Ritonavir Tablets, itraconazole
- Where
- 107 sites in United States, Australia and 2 more
- Volunteers
- 862 people
- Sponsor
- DualityBio Inc.
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
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
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
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
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
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
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
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