Clinical trials: sponsored by 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
Early-Stage Non-Small Cell Lung Cancer
A Study to Assess The Safety and Tolerability of Pumitamig-Based Therapy Administered Before Surgery in Participants With Early-Stage Non-Small Cell Lung Cancer (ROSETTA Lung-220)
The purpose of this study is to assess the safety, tolerability, and surgical feasibility of preoperative Pumitamig-based therapy and other molecules in resectable, Early-Stage Non-Small Cell Lung Cancer
- Trial name
- NCT07871214
- Testing
- Pumitamig, Carboplatin, Cisplatin
- Where
- 50 sites in United States, Australia and 12 more
- Volunteers
- 80 people
- Sponsor
- Bristol-Myers Squibb
Extensive-stage Small Cell Lung Carcinoma, Advanced Small Cell Lung Cancer
A Study to Test Obrixtamig in Combination With Pumitamig in People With Advanced Small Cell Lung Cancer (Dareon®-Rosetta35)
This study is open to adults with extensive-stage small cell lung cancer. The purpose of this study is to find out how well people with this type of cancer tolerate taking study medicines called obrixtamig and pumitamig.
- Trial name
- NCT07843940
- Testing
- Obrixtamig, Pumitamig, Carboplatin
- Where
- 27 sites in United States, Australia and 8 more
- Volunteers
- 55 people
- Sponsor
- Boehringer Ingelheim
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
Human Papilloma Virus Related Carcinoma, Head and Neck Neoplasm
HARE-40: HPV Anti-CD40 RNA vaccinE
HARE-40 is a phase I/II vaccine dose escalation study with two different arms: Arm 1A will perform intrapatient dose escalation in patients with previously treated HPV16+ Head \& Neck Cancer using two dose cohorts to establish a…
- Conditions
- Human Papilloma Virus Related Carcinoma, Head and Neck Neoplasm, Cervical Neoplasm, Penile Neoplasms Malignant
- Trial name
- HARE-40 (NCT03418480)
- Testing
- BNT113
- Where
- 2 sites in United Kingdom
- Volunteers
- 30 people
- Sponsor
- University of Southampton
Malignant Solid Tumor
A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors
This study evaluating GEN1042 will include multiple parts. In this study, GEN1042 alone (phase 1a) or GEN1042 in combination with other anticancer drug(s) (phase 1b) will be evaluated in Japanese participants.
- Trial name
- NCT06057038
- Testing
- GEN1042, Pembrolizumab, Cisplatin
- Where
- 3 sites in Japan
- Volunteers
- 8 people
- Sponsor
- Genmab
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
Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204)
The purpose of this study is to evaluate the safety and efficacy of Pumitamig in combination with chemotherapy versus Nivolumab in combination with chemotherapy in participants with previously untreated advanced or metastatic…
- Trial name
- NCT07221149
- Testing
- Pumitamig, Folfox, Capox
- Where
- 161 sites in United States, Argentina and 18 more
- Volunteers
- 690 people
- Sponsor
- Bristol-Myers Squibb
Non-small Cell Lung Cancer (NSCLC)
A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
- Trial name
- NCT07361497
- Testing
- Pumitamig, Durvalumab
- Where
- 260 sites in United States, Argentina and 30 more
- Volunteers
- 850 people
- Sponsor
- Bristol-Myers Squibb
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
Metastatic Breast Cancer
A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)
The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+…
- Trial name
- NCT06018337
- Testing
- DB-1303/BNT323, Capecitabine, Paclitaxel
- Where
- 258 sites in United States, Argentina and 15 more
- Volunteers
- 541 people
- Sponsor
- DualityBio Inc.
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
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
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
This is a Phase II, multi-site, open-label, parallel group study in participants with untreated extended-stage small-cell lung cancer (ES-SCLC) (Cohort 1) or small-cell lung cancer (SCLC) which has progressed on first- or…
- Trial name
- NCT06449209
- Testing
- BNT327 Dose Level 1 (DL1), BNT327 Dose Level 2 (DL2), Etoposide
- Where
- 64 sites in United States, Australia and 3 more
- Volunteers
- 110 people
- Sponsor
- BioNTech SE
Adenocarcinoma, Pancreatic Ductal
A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC
The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone…
- Trial name
- IMCODE003 (NCT05968326)
- Testing
- Autogene cevumeran, Atezolizumab, mFOLFIRINOX
- Where
- 87 sites in United States, Belgium and 8 more
- Volunteers
- 260 people
- Sponsor
- Genentech, Inc.
Advanced Solid Tumor
Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors
This is a first-in-human (FIH), open-label, multi-site study which will evaluate the safety, efficacy, tolerability, pharmacokinetics (PK), and immunogenicity of increasing doses of BNT317 in participants with advanced solid…
- Trial name
- NCT06750185
- Testing
- BNT317 DL1, BNT317 DL2, BNT317 DL3
- Where
- 11 sites in United States, Australia
- Volunteers
- 248 people
- Sponsor
- BioNTech SE
HIV -1 Infection
A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV
This study will test the safety and blood levels of the antibody BNT351 in people living without and with human immunodeficiency virus (HIV).
- Trial name
- NCT07392372
- Testing
- BNT351
- Where
- 6 sites in United States, Germany
- Volunteers
- 67 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
HER2-positive Advanced Solid Tumor
A Phase 1/2a Study of DB-1303/BNT323 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-1303/BNT323 in subjects with advanced solid tumors that express HER2.
- Trial name
- NCT05150691
- Testing
- DB-1303/BNT323, Pertuzumab Injection, Ritonavir
- Where
- 102 sites in United States, Australia and 4 more
- Volunteers
- 796 people
- Sponsor
- DualityBio Inc.