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 is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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 cytologically confirmed solid tumors that are advanced (i.e., either metastatic or recurrent tumors with no further definitive treatment possible) and/or have relapsed/progressed after prior therapy.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek co najmniej 18 lat
  • Potwierdzony zaawansowany nowotwór (przerzutowy lub nawracający) udokumentowany badaniem histologicznym lub cytologicznym
  • Mierzalne zmiany nowotworowe
  • Dobry stan ogólny (ECOG 0 lub 1)
  • Prawidłowa funkcja narządów i szpiku kostnego
  • W czerniaków: wcześniejsze leczenie lekami hamującymi PD-1 lub PD-L1 oraz (jeśli wymagane) lekami celowanymi na mutacje BRAF
  • W raku płuca: zaawansowana choroba niedająca się radykalnie leczyć
  • W raku płuca bez mutacji: brak zmian genetycznych, dla których dostępne są terapie celowane

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 22, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (67)

Mayo Clinic Arizona

Phoenix, United States

University of California San Francisco

San Francisco, United States

Hartford Healthcare

Hartford, United States

Yale University

New Haven, United States

Florida Cancer Specialists

Sarasota, United States

Moffitt Cancer Center

Tampa, United States

Dana Farber Cancer Institute

Boston, United States

Massachusetts General Hospital

Boston, United States

Brigitte Harris Cancer Pavilion BHCP

Detroit, United States

START Midwest, LLC

Grand Rapids, United States

Memorial Sloan Kettering Hospital

New York, United States

Duke Cancer Institute

Durham, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, United States

University of Pittsburgh Medical Center

Pittsburgh, United States

The University of Texas MD Anderson Cancer Center

Houston, United States

South Texas Accelerated Research Therapeutics (START), LLC

San Antonio, United States

START Mountain Region

West Valley City, United States

The Board of Regents of the University of Wisconsin

Madison, United States

Blacktown Hospital

Blacktown, Australia

St Vincent's Hospital Sydney

Darlinghurst, Australia

Melanoma Institute Australia

Wollstonecraft, Australia

Tasman Oncology Research Ltd

Southport, Australia

Cancer Research SA

Adelaide, Australia

Peninsula and South Eastern Haematology & Oncology Group

Frankston, Australia

Austin Health

Heidelberg, Australia

The Alfred Hospital

Melbourne, Australia

One Clinical Research Pty Ltd

Nedlands, Australia

Universitair Ziekenhuis Gent

Ghent, Belgium

Centre hospitalier universitaire de Liège

Liège, Belgium

Ziekenhuis Aan de Stroom ZAS vzw

Wilrijk, Belgium

Charité - Campus Charité Mitte

Berlin, Germany

Universitaetsklinikum Essen

Essen, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Germany

Klinikum der Universität München Campus Grosshadern

München, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

Meldola, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

IEO Istituto Europeo di Oncologia

Milan, Italy

Istituto Nazionale Tumori Fondazione G. Pascale

Naples, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Istituto Clinico Humanitas

Rozzano, Italy

Hospital Universitari Vall d'Hebron - VHIO

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

START Barcelona -HM Nou Delfos

Barcelona, Spain

Hospital de San Pedro

Logroño, Spain

Hospital Beata Maria Ana

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Centro Integral Oncologico Clara Campal

Madrid, Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Dr. Abdurrahman Yurtaslan Ankara Oncology Traning & Research

Ankara, Turkey (Türkiye)

Hacettepe Oncology Hospital

Ankara, Turkey (Türkiye)

Ankara Bilkent City Hospital Phase 1 Clinical Research Cente

Ankara, Turkey (Türkiye)

Yeditepe University Kosuyolu Hospital

Istanbul, Turkey (Türkiye)

Queen Elizabeth Hospital

Birmingham, United Kingdom

Velindre Cancer Centre

Cardiff, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

The Clatterbridge Cancer Centre

Liverpool, United Kingdom

Royal Free Hospital

London, United Kingdom

Royal Marsden Hospital-London

London, United Kingdom

Imperial College London

London, United Kingdom

University College London Hospitals

London, United Kingdom

The Christie Hospital

Manchester, United Kingdom

Northern Centre for Cancer Care

Newcastle upon Tyne, United Kingdom

Southampton General Hospital

Southampton, United Kingdom

Royal Marsden Hospital

Sutton, United Kingdom

Trial contact

BioNTech clinical trials patient information

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/23/2026.

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