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BioNTech clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine and the EU Clinical Trials Information System (CTIS) — current trials in our USA, UK, China and EU (CTIS) registers with BioNTech as lead sponsor. Synced 26 Sep 2026
30Current trials
21Recruiting now
24Drugs in these trials
4Trial registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist
Compiled from ClinicalTrials.gov and CTIS registry records · Last verified · Editorial standards
At a glance

BioNTech is the lead sponsor of 30 current clinical trials in our USA, UK, China and EU (CTIS) registers. 21 are recruiting patients now. The most common phase is Phase 1/2. The drugs named most often in its trials are Pumitamig, Carboplatin and Paclitaxel. The most-studied condition is Advanced Solid Tumor.

Company profile on this site (news, sites, medicines, approvals): BioNTech SE (DE) →

ClinicalTrials.gov trials by status

  • Recruiting2175%
  • Active, closed725%

Trials by phase

  • Phase 1/2932%
  • Phase 2621%
  • Phase 3518%
  • Phase 1518%
  • Phase 2/327%
  • Phase 414%
01

Clinical trials sponsored by BioNTech

28 on ClinicalTrials.gov
StudyPhaseStatusStartRegisters
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
NCT07070232 · Advanced Solid Tumor
Phase 1/2 Recruiting 2025-08 UK, USA, China
Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
NCT06712355 · Extensive-stage Small-cell Lung Cancer
Phase 3 Recruiting 2025-02 UK, USA, China
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
NCT07186842 · Advanced Solid Cancers
Phase 1/2 Recruiting 2025-11 UK, USA
A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer
NCT07365995 · Metastatic Castration-resistant Prostate Cancer
Phase 3 Recruiting 2026-04 UK, USA, China
Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer
NCT06712316 · ClinicalTrials.gov ↗ · Non-small Cell Lung Cancer
Phase 2/3 Recruiting 2025-01 UK, USA, China
A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV
NCT07392372 · HIV -1 Infection
Phase 1 Recruiting 2026-02 USA
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
NCT06340568 · ClinicalTrials.gov ↗ · Endometrial Cancer
Phase 3 Recruiting 2025-06 UK, USA, China
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)
NCT07111520 · ClinicalTrials.gov ↗ · Non-small Cell Lung Cancer
Phase 1/2 Recruiting 2025-09 UK, USA, China
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
NCT07079631 · ClinicalTrials.gov ↗ · Metastatic Colorectal Cancer
Phase 1/2 Recruiting 2025-07 UK, USA
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
NCT06827236 · ClinicalTrials.gov ↗ · Locally Advanced Breast Cancer, Unresectable Breast Carcinoma, Metastatic Breast Cancer
Drug: Pumitamig
Phase 1/2 Recruiting 2025-04 UK, USA, China
A Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of Age
NCT07730450 · COVID-19 Vaccines
Phase 4 Recruiting 2026-07 USA
Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
NCT05142189 · ClinicalTrials.gov ↗ · Non-Small Cell Lung Cancer
Phase 1 Recruiting 2022-06 UK, USA
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
NCT06841055 · ClinicalTrials.gov ↗ · Non-small Cell Lung Cancer
Phase 2 Recruiting 2025-03 UK, USA
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
NCT07173751 · ClinicalTrials.gov ↗ · Breast Neoplasms
Phase 3 Recruiting 2025-10 UK, USA, China
A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer
NCT06892548 · ClinicalTrials.gov ↗ · Advanced Lung Cancer
Phase 1/2 Recruiting 2025-05 UK, USA, China
A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIV
NCT07698600 · ClinicalTrials.gov ↗ · HIV -1 Infection
Phase 1 Recruiting 2026-08 USA
Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors
NCT06750185 · ClinicalTrials.gov ↗ · Advanced Solid Tumor
Phase 1/2 Recruiting 2025-01 USA
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
NCT07255404 · ClinicalTrials.gov ↗ · Pancreatic Ductal Adenocarcinoma (PDAC)
Phase 2 Recruiting 2025-12 China
Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors
NCT07455734 · ClinicalTrials.gov ↗ · Advanced Solid Tumor Cancer
Phase 1/2 Recruiting 2026-03 China
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma
NCT07297212 · ClinicalTrials.gov ↗ · Recurrent Glioblastoma
Phase 2 Recruiting 2026-01 China
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
NCT07147348 · ClinicalTrials.gov ↗ · Advanced Solid Tumor
Drug: Pumitamig
Phase 1/2 Recruiting 2025-08 China
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
NCT04486378 · Colorectal Cancer Stage II, Colorectal Cancer Stage III
Phase 2 Active, closed 2021-03 UK, USA
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
NCT06449209 · ClinicalTrials.gov ↗ · Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
Phase 2 Active, closed 2024-08 UK, USA
A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age
NCT07300839 · COVID-19, SARS-COV-2 Infection
Phase 3 Active, closed 2025-12 USA
A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1
NCT04534205 · ClinicalTrials.gov ↗ · Unresectable Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer
Phase 2/3 Active, closed 2021-01 UK, USA
Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy
NCT06449222 · ClinicalTrials.gov ↗ · Locally Advanced Breast Cancer, Triple Negative Breast Cancer, Metastatic Triple Negative Breast Cancers
Phase 2 Active, closed 2024-08 UK, USA
Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid Tumors
NCT06150183 · ClinicalTrials.gov ↗ · Advanced Malignant Solid Tumor
Drug: BNT314
Phase 1 Active, closed 2023-11 UK, USA
A Clinical Trial in Healthy Volunteers and Volunteers With Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions
NCT05432583 · ClinicalTrials.gov ↗ · Genital Herpes Simplex Type 2
Phase 1 Active, closed 2022-12 USA

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Titles and statuses are copied from the registry as published.

02

BioNTech in the EU trials register (CTIS)

2 trials

Authorised or ongoing trials in the EU Clinical Trials Information System with BioNTech as sponsor. Some are the same study as a ClinicalTrials.gov record above; the two registries share no common ID. Trials with a site in Ireland are listed first.

StudyPhaseStatusCountries
A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer
2025-524445-27-00 · Male Urogenital Diseases
Phase 3 Authorised Belgium, Spain, Italy + 3 more
A Phase III, multisite, randomized, double-blind trial of BNT327 in combination with chemotherapy versus placebo with chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic TNBC determined ineligible for PD(L)1 therapy based on PD-L1 negative disease
2025-521884-12-00 · CTIS ↗ · Neoplasms
Phase 3 Ongoing Czechia, Poland, Italy + 5 more
03

Drugs in BioNTech trials

24 compounds

Drugs and biologicals named as interventions in these trials, with the number of this sponsor's trials that name each one. Placebos and generic comparators are excluded.

04

Conditions in BioNTech trials

30 conditions
Advanced Solid Tumor3Non-small Cell Lung Cancer3Extensive-stage Small-cell Lung Cancer2Locally Advanced Breast Cancer2HIV -1 Infection2Colorectal Cancer Stage II1Colorectal Cancer Stage III1Advanced Solid Cancers1Metastatic Castration-resistant Prostate Cancer1Small-cell Lung Cancer1Endometrial Cancer1Metastatic Colorectal Cancer1Unresectable Head and Neck Squamous Cell Carcinoma1Metastatic Head and Neck Cancer1Recurrent Head and Neck Cancer1Unresectable Breast Carcinoma1Metastatic Breast Cancer1Non-Small Cell Lung Cancer1Triple Negative Breast Cancer1Metastatic Triple Negative Breast Cancers1Advanced Malignant Solid Tumor1Breast Neoplasms1Advanced Lung Cancer1COVID-191
05

By trial register

RegisterTrialsRecruiting
Clinical trials in USA2417
Clinical trials in UK1813
Clinical trials in China1313
EU register (CTIS)2—

A trial with sites in more than one country appears in each of those registers.

06

Other sponsors in Advanced Solid Tumor

SponsorTrials
BeOne Medicines11
Daiichi Sankyo7
TORL Biotherapeutics5
OncoC45
LaNova Medicines5
MediLink Therapeutics (Suzhou)4
Suzhou Zelgen Biopharmaceuticals4
EMD Serono Research & Development Institute3
Hansoh BioMedical R&D Company3
Qilu Pharmaceutical3

Sponsors with the most current trials registered for this condition.

07

Questions about BioNTech trials

How many clinical trials does BioNTech sponsor?

BioNTech is the lead sponsor of 28 current trials on ClinicalTrials.gov in our USA, UK and China registers, and 2 authorised or ongoing trials in the EU register (CTIS), as of the registry sync on 26 September 2026. Completed and withdrawn studies are not counted.

Are BioNTech trials recruiting?

Yes. 21 of its 28 ClinicalTrials.gov trials are recruiting. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Which drugs is BioNTech testing?

Its current trials name 24 drugs and biologicals as interventions. The most frequent are Pumitamig (13), Carboplatin (7), Paclitaxel (6), Docetaxel (5) and BNT324 (3). The number in brackets is how many of its trials name each drug.

Where does this information come from?

Every trial, status, phase and condition on this page is copied from public ClinicalTrials.gov and EU CTIS records by a daily sync, grouped by the sponsor name each registry records. It says nothing about the organisation beyond its registered trials, and it is not medical advice.

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How this page is built

Everything on this page is copied from public registry records — it is not written from memory, and nothing here describes the organisation beyond its registered trials. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our trial registers and groups every current trial by its lead sponsor name, ignoring legal-form suffixes such as Inc. or Ltd. A small, hand-checked list joins the same organisation's different registry names (for example its EU legal entity). There is no AI drafting and no per-sponsor editorial pass. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The the registries data on this page was last retrieved on 26 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.