Clinical trials: sponsored by BioNTech SE
Locally Advanced Breast Cancer, Triple Negative Breast Cancer
Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy
This study is a Phase II, multi-site, randomized, open-label clinical study to evaluate the safety, efficacy, and pharmacokinetics (PK) of BNT327 at two dose levels in combination with chemotherapeutic agents in the first- and…
- Conditions
- Locally Advanced Breast Cancer, Triple Negative Breast Cancer, Metastatic Triple Negative Breast Cancers
- Trial name
- NCT06449222
- Testing
- BNT327 Dose Level 1 (DL1), BNT327 Dose Level 1 (DL2), Nab-placlitaxel
- Where
- 31 sites in United States, Australia and 2 more
- Volunteers
- 83 people
- Sponsor
- BioNTech SE
Solid Tumor
A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ Tumors
This is a Phase I, FIH, open-label, multi-site, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of claudin 6 (CLDN6) chimeric antigen receptor T cells (CAR-T) with or without CLDN6…
- Trial name
- NCT04503278
- Testing
- CLDN6 CAR-T, CLDN6 uRNA-LPX/CLDN6 modRNA-LPX
- Where
- 12 sites in Australia, Germany and 2 more
- Volunteers
- 214 people
- Sponsor
- BioNTech Cell & Gene Therapies GmbH
Advanced Solid Tumor
A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors
The aim of this first-in-human (FIH) open-label, multi-site study is to evaluate safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary clinical efficacy of BNT3212, including identification of the…
- Trial name
- NCT07147348
- Testing
- BNT3212, Pumitamig
- Where
- 17 sites in Australia, China
- Volunteers
- 375 people
- Sponsor
- BioNTech SE
MPM
A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with pemetrexed and platinum as first line treatment for MPM.
- Trial name
- NCT05918107
- Testing
- PM8002, Pemetrexed, Cisplatin
- Where
- 16 sites in China
- Volunteers
- 31 people
- Sponsor
- Biotheus Inc.
Melanoma, Non-Small Cell Lung Cancer
A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors
This is a Phase 1a/1b, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of autogene cevumeran (RO7198457) as a single agent and in…
- Conditions
- Melanoma, Non-Small Cell Lung Cancer, Bladder Cancer, Colorectal Cancer
- Trial name
- NCT03289962
- Testing
- Autogene cevumeran, Atezolizumab
- Where
- 33 sites in United States, Belgium and 6 more
- Volunteers
- 273 people
- Sponsor
- Genentech, Inc.
COVID-19, SARS-COV-2 Infection
A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Participants Ages 12 Through 64 Years Considered at Higher Risk of Severe COVID-19, and Participants Ages ≥65 Years
The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19.
- Trial name
- NCT07069309
- Testing
- BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)
- Where
- 19 sites in United States
- Volunteers
- 774 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
Colorectal Cancer Stage II, Colorectal Cancer Stage III
Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant Chemotherapy
This is a multi-site epidemiological study designed to monitor circulating tumor DNA (ctDNA) status in participants with Stage II (high risk)/III colorectal cancer (CRC) following resection/prior to adjuvant chemotherapy (AdCTx)…
- Trial name
- NCT04813627
- Testing
- Regular blood sample collection for ctDNA assessment
- Where
- 74 sites in United States, Belgium and 2 more
- Volunteers
- 2,079 people
- Sponsor
- BioNTech SE
Non Small Cell Lung Cancer, Breast Cancer
A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer
This is a phase 1, multicenter, open-label, first-in-human study of YL202 conducted in the United States and China. The study will evaluate the safety and tolerability of YL202 in patients with locally advanced or metastatic…
- Trial name
- NCT05653752
- Testing
- YL202
- Where
- 13 sites in United States, China
- Volunteers
- 80 people
- Sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
Advanced Solid Tumor
First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1305/BNT325 in subjects with advanced solid tumors.
- Trial name
- NCT05438329
- Testing
- DB-1305/BNT325, Pembrolizumab, BNT327
- Where
- 93 sites in United States, China and 1 more
- Volunteers
- 1,123 people
- Sponsor
- DualityBio Inc.
Advanced Non-Small Cell Lung Cancer
A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1)
This study is researching an investigational drug, called BNT116, in combination with cemiplimab. BNT116 and cemiplimab will each be called a "study drug", and together be called "study drugs".
- Trial name
- NCT05557591
- Testing
- BNT116, Cemiplimab
- Where
- 52 sites in United States, Georgia and 5 more
- Volunteers
- 51 people
- Sponsor
- Regeneron Pharmaceuticals
Shingles, Herpes Zoster Infection
A Study to Learn About a Modified RNA Vaccine Against Shingles in Healthy Adults
The purpose of this clinical study is to learn about the safety, extent of the side effects (reaction to vaccine), and immune response (your immune system's reaction) of the study vaccine called Varicella Zoster Virus modRNA (VZV…
- Conditions
- Shingles, Herpes Zoster Infection, Human
- Trial name
- NCT05703607
- Testing
- Candidate 1: PF-07915234: VZV modRNA Powder for Suspension for Injection, Candidate 1: PF-07915234: VZV modRNA Suspension for Injection, Candidate 2: PF-07921188: VZV modRNA Suspension for Injection
- Where
- 35 sites in United States
- Volunteers
- 484 people, healthy volunteers welcome
- Sponsor
- Pfizer
SARS-CoV-2 Infection, COVID-19
A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals
The purpose of this clinical protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people.
- Trial name
- NCT05997290
- Testing
- BNT162b2 (Omi XBB.1.5), BNT162b2 (Omi JN.1), BNT162b2 (Omi KP.2)
- Where
- 37 sites in United States
- Volunteers
- 1,051 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Non-small Cell Lung Cancer
Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment
This is a Phase II, multisite, open-label study consisting of two parts in participants with advanced/metastatic Non-small Cell Lung Cancer (NSCLC) which progressed after a first-line chemoimmunotherapy to evaluate the…
- Trial name
- NCT06841055
- Testing
- Pumitamig, Docetaxel
- Where
- 30 sites in United States, Australia and 4 more
- Volunteers
- 60 people
- Sponsor
- BioNTech SE
Solid Tumor
Safety and Preliminary Efficacy Trial of BNT142 in Patients With CLDN6-positive Solid Tumors
This study is an open-label, multicenter, Phase I/IIa, dose escalation, safety, and pharmacokinetics (PK) study of BNT142 followed by expansion cohorts in patients with Claudin 6 (CLDN6)-positive advanced tumors.
- Trial name
- NCT05262530
- Testing
- BNT142
- Where
- 18 sites in United States, Singapore and 2 more
- Volunteers
- 73 people
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals.
- Trial name
- NCT04368728
- Testing
- BNT162b1, BNT162b2, BNT162b2SA
- Where
- 175 sites in United States, Argentina and 4 more
- Volunteers
- 46,969 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2
Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population
This was a phase II, randomized, placebo-controlled, observer-blinded study of the safety and immunogenicity of SARS-CoV-2 messenger RNA (mRNA) vaccine (BNT162b2) in Chinese healthy population.
- Trial name
- NCT04649021
- Testing
- BNT162b2
- Where
- China
- Volunteers
- 960 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Tuberculosis
Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers
This is a two-part randomized, placebo-controlled, observer-blind, safety and dose-finding Phase Ib/IIa study. This study will evaluate up to four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to…
- Trial name
- NCT05547464
- Testing
- BNT164a1, BNT164b1
- Where
- 8 sites in Mozambique, South Africa
- Volunteers
- 497 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Breast Cancer (Triple Negative Breast Cancer (TNBC))
RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID
The Mutanome Engineered RNA Immuno-Therapy (MERIT) study introduced a novel concept for Individualized Cancer Immunotherapy (IVAC®) to treat each patient with the relevant and immunogenic RNA vaccines for a given patient's tumor.
- Trial name
- TNBC-MERIT (NCT02316457)
- Testing
- IVAC_W_bre1_uID, IVAC_W_bre1_uID/IVAC_M_uID
- Where
- 4 sites in Germany, Sweden
- Volunteers
- 42 people
- Sponsor
- BioNTech SE
Melanoma
Evaluation of the Safety and Tolerability of i.v. Administration of a Cancer Vaccine in Patients With Advanced Melanoma
The purpose of this study is to determine the safety and tolerability of intravenous administration of a tetravalent RNA-lipoplex cancer vaccine targeting four tumor-associated antigens in patients with advanced melanoma.
- Trial name
- Lipo-MERIT (NCT02410733)
- Testing
- Lipo-MERIT
- Where
- 4 sites in Germany
- Volunteers
- 119 people
- Sponsor
- BioNTech SE