Organization
BioNTech
45 clinical trials
4 abstracts
Clinical trial
A Phase III, Randomized, Multi-site, Open-label Trial of BNT323/DB-1303 Versus Investigator's Choice of Chemotherapy in Previously Treated Patients With HER2- Expressing Recurrent Endometrial CancerStatus: Not yet recruiting, Estimated PCD: 2026-10-01
Clinical trial
Open-label, Randomized Phase II Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV MelanomaStatus: Active (not recruiting), Estimated PCD: 2025-11-01
Clinical trial
An Exploratory Phase I, Randomized, Observer-blind, Active-controlled, Dose-escalation Trial Evaluating the Safety, Tolerability, and Immunogenicity of an Investigational RNA-based SARS-CoV-2 Vaccine in COVID-19 Vaccine Experienced Healthy AdultsStatus: Active (not recruiting), Estimated PCD: 2024-10-01
Clinical trial
A Randomized, Partially Observer-blind, Dose-escalation, Phase I/II Trial Evaluating the Safety and Immunogenicity of Investigational RNA-based Mpox Vaccine CandidatesStatus: Recruiting, Estimated PCD: 2024-10-01
Clinical trial
A Phase Ia, Randomized, Placebo-controlled, Double-blind, Dose-finding Evaluation Trial to Describe the Safety, Reactogenicity, and Immunogenicity of Two Investigational Vaccines Against Tuberculosis in IGRA-negative, BCG naïve SubjectsStatus: Recruiting, Estimated PCD: 2024-09-01
Clinical trial
A PHASE 2/3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b2 RNA-BASED VACCINE CANDIDATES FOR SARS-CoV-2 NEW VARIANTS IN HEALTHY INDIVIDUALSStatus: Active (not recruiting), Estimated PCD: 2024-12-09
Clinical trial
First-in-human, Dose Titration and Expansion Trial to Evaluate Safety, Immunogenicity and Preliminary Efficacy of W_pro1 (BNT112) Monotherapy and in Combination With Cemiplimab in Patients With Prostate CancerStatus: Terminated, Estimated PCD: 2024-01-23
Clinical trial
A MASTER PHASE 1/2/3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF VARIANT-ADAPTED BNT162b2 RNA-BASED VACCINE CANDIDATE(S) IN HEALTHY CHILDRENStatus: Recruiting, Estimated PCD: 2025-08-11
Clinical trial
A PHASE 1, OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY AND PHASE 2/3 PLACEBO-CONTROLLED, OBSERVER-BLINDED SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY CHILDRENStatus: Completed, Estimated PCD: 2023-10-04
Clinical trial
A PHASE 1/2 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED MODIFIED RNA VACCINE CANDIDATES AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALSStatus: Completed, Estimated PCD: 2023-12-28
Clinical trial
First-in-human, Open-label, Multicenter, Phase I/IIa, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT142 in Patients With CLDN6-positive Advanced Solid TumorsStatus: Recruiting, Estimated PCD: 2025-10-01
Clinical trial
An Exploratory Phase I, Randomized, Observer-blind, Placebo-controlled Dose Escalation Trial Evaluating the Safety, Tolerability and Immunogenicity of an Investigational RNA-based Vaccine for Active Immunization Against MalariaStatus: Active (not recruiting), Estimated PCD: 2024-02-23
Clinical trial
A MASTER PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BIVALENT BNT162b2 RNA-BASED VACCINE CANDIDATE(S) IN HEALTHY INFANTS AND CHILDRENStatus: Withdrawn, Estimated PCD: 2026-07-13
Clinical trial
Phase I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid TumorsStatus: Active (not recruiting), Estimated PCD: 2024-05-31
Clinical trial
A Phase I/Randomized Phase II, Open-label Multicenter Trial to Evaluate the Safety, Tolerability, and Efficacy of mFOLFIRINOX With or Without BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic AdenocarcinomaStatus: Recruiting, Estimated PCD: 2029-04-01
Clinical trial
An Open Label Phase II Randomized Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as a First Line Therapy in Patients With Unresectable Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Which is Positive for Human Papilloma Virus 16 (HPV16+) and Expresses PD-L1 (AHEAD-MERIT)Status: Recruiting, Estimated PCD: 2028-05-01
Clinical trial
A PHASE 3, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A COMBINED MODIFIED RNA VACCINE CANDIDATE AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALSStatus: Recruiting, Estimated PCD: 2024-12-05
Clinical trial
Phase I, First-in-human, Open-label, Dose Escalation Trial to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of BNT152+153 in Patients With Solid TumorsStatus: Recruiting, Estimated PCD: 2025-09-01
Clinical trial
Phase 1/2a, First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BNT411 as a Monotherapy in Patients With Solid Tumors and in Combination With Atezolizumab, Carboplatin and Etoposide in Patients With Chemotherapy-naïve Extensive-stage Small Cell Lung Cancer (ES-SCLC)Status: Active (not recruiting), Estimated PCD: 2024-01-19
Clinical trial
LuCa-MERIT-1: First-in-human, Open Label, Phase I Dose Confirmation Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung CancerStatus: Recruiting, Estimated PCD: 2026-01-01
Clinical trial
A Randomized, Dose-escalation Phase I/IIa Trial With Controlled Human Malaria Infection to Evaluate Safety, Tolerability, Immunogenicity and Efficacy of an Investigational RNA-based Vaccine for Prevention of P. Falciparum Malaria in Healthy Malaria naïve AdultsStatus: Recruiting, Estimated PCD: 2025-06-01
Clinical trial
AN INTERVENTIONAL, RANDOMIZED, ACTIVE-CONTROLLED, PHASE 1/2/3 STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b RNA-BASED VACCINE CANDIDATES IN COVID-19 VACCINE-EXPERIENCED HEALTHY INDIVIDUALSStatus: Completed, Estimated PCD: 2024-03-26
Clinical trial
An Open-label, Phase I Study of NEO-PTC-01 in Patients With Advanced or Metastatic MelanomaStatus: Recruiting, Estimated PCD: 2025-10-31
Clinical trial
Phase I, Randomized, Observer-blinded, Placebo-controlled, 2-part, Dose Escalation and Expanded Safety Evaluation Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Prophylactic Vaccine for the Prevention of Genital Lesions Caused by Herpes Simplex Virus (HSV)-2 and Potentially HSV-1Status: Recruiting, Estimated PCD: 2025-12-01
Clinical trial
A Phase Ib/IIa Two-part, Randomized, Placebo-controlled, Observer-blind, Dose-finding Evaluation Trial to Describe the Safety, Reactogenicity, and Immunogenicity of Two Investigational Vaccines Against Tuberculosis in BCG Vaccinated, HIV-negative Subjects and People Living With HIVStatus: Recruiting, Estimated PCD: 2026-03-01
Clinical trial
A First-in-Human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate the Safety and Preliminary Efficacy of BNT314 in Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Patients With Advanced Malignant Solid TumorsStatus: Recruiting, Estimated PCD: 2030-02-01
Clinical trial
A Multi-site, Open-label, Phase II, Randomized, Controlled Trial to Compare the Efficacy of RO7198457 Versus Watchful Waiting in Resected, Stage II (High Risk) and Stage III Colorectal Cancer Patients Who Are ctDNA Positive Following ResectionStatus: Recruiting, Estimated PCD: 2026-02-01
Clinical trial
A PHASE 3 MASTER PROTOCOL TO EVALUATE ADDITIONAL DOSE(S) OF BNT162B2 IN HEALTHY INDIVIDUALS PREVIOUSLY VACCINATED WITH BNT162B2Status: Completed, Estimated PCD: 2023-05-25
Clinical trial
A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, AND OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY JAPANESE ADULTSStatus: Completed, Estimated PCD: 2021-11-25
Clinical trial
A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE FORMULATIONS OF THE VACCINE CANDIDATE BNT162B2 AGAINST COVID 19 IN HEALTHY ADULTS 18 THROUGH 55 YEARS OF AGEStatus: Completed, Estimated PCD: 2021-12-01
Clinical trial
A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALSStatus: Completed, Estimated PCD: 2023-02-10
Clinical trial
A Phase II, Open-label, Rollover Trial to Evaluate the Safety and Immunogenicity of One or Two Boosting Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 Trial Subjects, or Two Boosting Doses of Comirnaty in BNT162-04 Trial SubjectsStatus: Completed, Estimated PCD: 2022-04-14
Clinical trial
Phase I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BNT141 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With CLDN18.2-positive Solid TumorsStatus: Terminated, Estimated PCD: 2023-07-24
Clinical trial
A PHASE 3, RANDOMIZED, OBSERVER-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF BNT162b2 WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE (SIIV) IN ADULTS 18 THROUGH 64 YEARS OF AGEStatus: Completed, Estimated PCD: 2022-10-05
Clinical trial
Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects: A Phase I, Randomized, Placebo-controlled, Observer-blind StudyStatus: Completed, Estimated PCD: 2020-09-30
Clinical trial
A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE PRODUCTION LOTS AND DOSE LEVELS OF THE VACCINE CANDIDATE BNT162b2 AGAINST COVID-19 IN HEALTHY PARTICIPANTS 12 THROUGH 50 YEARS OF AGE AND THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b2 RNA-BASED COVID-19 VACCINE CANDIDATES AS A BOOSTER DOSE IN HEALTHY PARTICIPANTS 18 THROUGH 50 YEARS OF AGEStatus: Completed, Estimated PCD: 2021-07-22
Clinical trial
A PHASE 2b, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF VACCINE CANDIDATE BNT162b2 IN IMMUNOCOMPROMISED PARTICIPANTS ≥2 YEARS OF AGEStatus: Completed, Estimated PCD: 2023-07-23
Clinical trial
A Phase II Trial to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Monovalent and Multivalent RNA-based Vaccines in Healthy SubjectsStatus: Completed, Estimated PCD: 2023-08-16
Clinical trial
A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of a Prophylactic SARS-CoV-2 RNA Vaccine (BNT162b3) Against COVID-19 Using Different Dosing Regimens in Healthy AdultsStatus: Completed, Estimated PCD: 2021-03-12
Clinical trial
A PHASE 2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE (BNT162b2) AGAINST COVID-19 IN HEALTHY PREGNANT WOMEN 18 YEARS OF AGE AND OLDERStatus: Completed, Estimated PCD: 2022-07-15
Clinical trial
First-in-human Clinical Study With RNA-Immunotherapy Combination of IVAC_W_bre1_uID and IVAC_M_uID for Individualized Tumor Therapy in Triple Negative Breast Cancer PatientsStatus: Completed, Estimated PCD: 2020-05-13
Clinical trial
Clinical First-in-human Dose Escalation Study Evaluating the Safety and Tolerability of Intravenous Administration of a Tetravalent RNA-lipoplex Cancer Vaccine Targeting the Tumor-associated Antigens NY-ESO-1, Tyrosinase, MAGE-A3, and TPTE in Patients With Advanced MelanomaStatus: Completed, Estimated PCD: 2023-06-20
Abstract
Real-world evidence of overall survival (OS) and treatment patterns of patients (pts) with testicular germ cell tumors (GCT) receiving palliative chemotherapy in the United States.Org: Memorial Sloan Kettering Cancer Center, New York, NY, BioNTech, New Kensignton, PA, Analysis Group, Inc.,
Clinical trial
A Phase II, Multi-site, Open-label, Parallel Group Trial of BNT327 in Combination With Chemotherapy for Participants With Untreated Extensive-stage Small-cell Lung Cancer and Participants With Previously Treated Small-cell Lung CancerStatus: Not yet recruiting, Estimated PCD: 2025-02-01
Clinical trial
A Phase II, Multi-site, Randomized, Open-label Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT327 at Two Dose Levels in Combination With Chemotherapeutic Agents as First- and Second-line Treatment in Triple-negative Breast CancerStatus: Not yet recruiting, Estimated PCD: 2025-02-01
Abstract
A phase I/II dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of BNT142 in patients with prospectively confirmed claudin 6-positive solid tumors.Org: Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Virginia Cancer Specialists, BioNTech,
Abstract
A phase I/II dose escalation and expansion trial to evaluate safety and preliminary efficacy of BNT141 in patients with claudin-18.2-positive solid tumors.Org: Centre Hospitalier de l’Université de Montréal (CHUM), Centre de Recherche du CHUM (CRCHUM), Université de Montréal, Princess Margaret Cancer Centre, The University of Texas MD Anderson Cancer Center, Stem Cell Transplantation Rsch, Houston, TX,
Abstract
CLDN6 CAR-T cell therapy of relapsed/refractory solid tumors ± a CLDN6-encoding mRNA vaccine: Dose escalation data from the BNT211-01 phase 1 trial using an automated product.Org: Friedrich-Alexander University Erlangen-Nuremberg, Netherlands Cancer Institute, Hannover Medical School, University Hospital Hamburg Eppendorf, University Medical Center Mainz,
Clinical trial
A Phase I Randomized, Double-blind, Placebo-controlled, Safety, Tolerability, and Pharmacokinetic Trial of BNT331 Administered in Single Ascending Doses in Healthy Women and Multiple Ascending Doses in Women Diagnosed With Bacterial VaginosisStatus: Not yet recruiting, Estimated PCD: 2025-05-01