BioNTech SE: Clinical Trials

23 recruiting, 18 completed, 10 active not recruiting, 10 terminated. 65 Phase 2, 35 Phase 1, 8 Phase 3.

By phase and status

Phase	Trials	Status
Phase 2	65	Recruiting 23, Completed 18, Active not recruiting 10, Terminated 10, Not yet recruiting 2, Withdrawn 2
Phase 1	35	Recruiting 14, Terminated 10, Completed 7, Active not recruiting 3, Not yet recruiting 1
Phase 3	8	Completed 4, Recruiting 3, Active not recruiting 1

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Trials (filtered) newest first · largest first

All 65 trials

Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
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) Pumitamig, Carboplatin, Cisplatin - Early-Stage Non-Small Cell Lung Cancer	Phase 2	Not yet recruiting	Bristol-Myers Squibb	80	2026-11-30	2026-10-13
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 BNT3210 - Advanced Solid Tumors	Phase 1 / Phase 2	Not yet recruiting	BioNTech SE	173	2026-11-01	2026-10-21
A Study to Test Obrixtamig in Combination With Pumitamig in People With Advanced Small Cell Lung Cancer (Dareon®-Rosetta35) Obrixtamig, Pumitamig, Carboplatin - Extensive-stage Small Cell Lung Carcinoma, Advanced Small Cell Lung Cancer	Phase 1 / Phase 2	Recruiting	Boehringer Ingelheim	55	2026-10-01	2026-10-13
Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors BNT3214 - Advanced Solid Tumor Cancer	Phase 1 / Phase 2	Recruiting	BioNTech SE	533	2026-03-30	2026-08-13
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) Pumitamig, Ipilimumab, Cabozantinib - Advanced Renal Cell Carcinoma (RCC)	Phase 1 / Phase 2	Recruiting	Bristol-Myers Squibb	474	2026-03-26	2026-10-23
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) Pumitamig, Ipilimumab - Hepatocellular Carcinoma (HCC)	Phase 1 / Phase 2	Recruiting	Bristol-Myers Squibb	198	2026-03-16	2026-10-23
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) Pumitamig, Folfox, Capox - Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma	Phase 2 / Phase 3	Recruiting	Bristol-Myers Squibb	690	2026-03-13	2026-09-30
A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa BNT166a, Placebo - Mpox (Monkeypox), Smallpox	Phase 2	Recruiting	BioNTech SE	310	2026-02-20	2026-08-11
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma Pumitamig, Bevacizumab, Temozolomide - Recurrent Glioblastoma	Phase 2	Recruiting	BioNTech SE	75	2026-01-15	2026-10-28
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 Pumitamig, FOLFOX, FOLFIRI - Untreated, Unresectable, or Metastatic Colorectal Cancer	Phase 2 / Phase 3	Recruiting	Bristol-Myers Squibb	990	2025-12-31	2026-10-23
A Clinical Trial Testing the Safety of Pumitamig (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have Not Been Treated Yet for Pancreatic Cancer Pumitamig, Nab-paclitaxel, Gemcitabine - Pancreatic Ductal Adenocarcinoma (PDAC)	Phase 2	Recruiting	BioNTech SE	105	2025-12-04	2026-07-28
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 BNT329, CA19-9-targeting monoclonal antibody - Advanced Solid Cancers	Phase 1 / Phase 2	Recruiting	BioNTech SE	245	2025-11-18	2026-10-15
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) BNT326, Pumitamig - Non-small Cell Lung Cancer	Phase 1 / Phase 2	Recruiting	BioNTech SE	880	2025-09-22	2026-10-22
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 BNT3212, Pumitamig - Advanced Solid Tumor	Phase 1 / Phase 2	Recruiting	BioNTech SE	375	2025-08-27	2026-06-15
PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer PM8002, Chemotherapy Regimen 1, Chemotherapy Regimen 2 - CRC (Colorectal Cancer)	Phase 2	Recruiting	Biotheus Inc.	100	2025-08-19	2026-07-23
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 BNT326, Pumitamig, Itraconazole - Advanced Solid Tumor	Phase 1 / Phase 2	Recruiting	BioNTech SE	1438	2025-08-12	2026-10-09
A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment Pumitamig (BNT327) and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer BNT314, Pumitamig, SoC chemotherapy treatment 1 - Metastatic Colorectal Cancer	Phase 1 / Phase 2	Recruiting	BioNTech SE	482	2025-07-18	2026-07-01
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors DB-1311/BNT324, BNT327, DB-1305/BNT325 - Solid Tumors	Phase 2	Recruiting	DualityBio Inc.	750	2025-07-18	2026-10-29
A Clinical Study Investigating the Therapeutic Effects and Safety of an Investigational Cell Therapy Given With and Without an Additional Investigational Product in Males With Testicular Cancer or a Form of Cancer That Developed From Sperm CLDN6 CAR-T, CLDN6 RNA-LPX - Testicular Germ Cell Tumor, Extragonadal Germ Cell Tumor	Phase 2	Withdrawn	BioNTech SE		2025-07-01	2025-07-02
A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer BNT324, BNT327 - Advanced Lung Cancer	Phase 1 / Phase 2	Recruiting	BioNTech SE	594	2025-05-02	2026-08-26

Showing 20 of 65. Sign in to see all of them.

Conditions studied

COVID-19 (13)  ·  Carcinoma, Non-Small-Cell Lung (11)  ·  Colorectal Neoplasms (6)  ·  Coronavirus Infections (5)  ·  Melanoma (5)  ·  Small Cell Lung Carcinoma (5)  ·  Stomach Neoplasms (5)  ·  Squamous Cell Carcinoma of Head and Neck (4)  ·  Carcinoma, Hepatocellular (3)  ·  Influenza, Human (3)  ·  Neoplasm Metastasis (3)  ·  Neoplasms (3)  ·  Pancreatic Neoplasms (3)  ·  Severe Acute Respiratory Syndrome (3)  ·  Virus Diseases (3)

Interventions

BNT162 Vaccine (8)  ·  pembrolizumab (8)  ·  Carboplatin (7)  ·  Paclitaxel (5)  ·  Gemcitabine (4)  ·  Bevacizumab (3)  ·  Etoposide (3)  ·  Itraconazole (3)  ·  Pemetrexed (3)  ·  cemiplimab (3)  ·  130-nm albumin-bound paclitaxel (2)  ·  Cisplatin (2)  ·  Folfox protocol (2)  ·  Injections (2)  ·  Ipilimumab (2)

Countries

United States (50)  ·  Spain (29)  ·  United Kingdom (28)  ·  Germany (27)  ·  Australia (26)  ·  China (21)  ·  South Korea (16)  ·  Italy (15)  ·  France (13)  ·  Turkey (Türkiye) (13)  ·  Taiwan (12)  ·  Poland (11)  ·  Canada (10)  ·  Belgium (9)  ·  Japan (8)

Top investigators

Lily Hu (2)  ·  Christian Ottensmeier, Prof (1)  ·  Ioannis Karydis, Dr (1)  ·  Ruihua Xu, PhD, MD (1)

Results publications

PMID 38400102, PMID 39066372, PMID 39197299, PMID 32785213, PMID 33053279, PMID 33301246, PMID 33524990, PMID 34043894, PMID 34525277, PMID 35131133, PMID 35316227, PMID 35472295, PMID 35473709, PMID 35653438, PMID 35688554, PMID 35739094, PMID 35792746, PMID 36055877, PMID 36120090, PMID 36125366, PMID 36378074, PMID 37527039, PMID 37592303, PMID 37860278, PMID 38012751, PMID 38016021, PMID 38366591, PMID 38776391, PMID 39097927, PMID 39999538, PMID 40237463, PMID 40245769, PMID 40347227, PMID 40396505, PMID 40591130, PMID 40970572, PMID 41530185, PMID 42235570, PMID 42286358

NIH funding

2023 (9), 2025 (6), 2018 (3), 2019 (2), 2014 (1)