Pharmaceutical sponsor
BioNTech SE Clinical Trials
Studies where BioNTech SE is the lead sponsor: its pipeline by phase, what is enrolling now and where. Studies it supports as a collaborator are in the search.
In numbers
Open to volunteers: recruiting, not yet recruiting or enrolling by invitation. Active adds studies under way that have stopped recruiting.
Open to volunteers
All 25Advanced 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
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
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
Completed, with results posted
All 25Bacterial 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
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
Malaria
A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
This was a randomized, dose-escalation Phase I/IIa study to evaluate safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P.
- Trial name
- NCT06069544
- Testing
- BNT165c, BNT165d
- Where
- 5 sites in United States
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Influenza,Human, COVID-19
A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People
This study is to learn about flu and COVID vaccines, either alone or when mixed together. Healthy people aged 18 or older can join. Participants will get one shot in each arm, either a flu or COVID vaccine, alone or mixed.
- Trial name
- NCT06683352
- Testing
- Investigational Influenza Vaccine, COVID-19 Vaccine, Investigational Influenza/COVID-19 Vaccine
- Where
- 22 sites in United States
- Volunteers
- 1,353 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children
This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and…
- Trial name
- NCT04816643
- Testing
- Biological/Vaccine: BNT162b2 10mcg, BNT162b2 20mcg, BNT162b2 30mcg
- Where
- 128 sites in United States, Brazil and 4 more
- Volunteers
- 11,837 people, healthy volunteers welcome
- Sponsor
- BioNTech SE