BioNTech launches trial of BNT326 for advanced cancers

NCT ID NCT07070232

Disease control Sponsor: BioNTech SE Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 4 times

Summary

This study tests a new drug called BNT326, given alone or with other cancer immunotherapies, in about 980 adults with advanced solid tumors that have spread or come back after prior treatment. The goal is to find the best dose and see if it is safe and effective. It is an early-stage trial, so results will help guide future research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: BNT326 (a drug given by IV infusion)
What this could lead to: If successful, this could point toward a new treatment option for people with advanced solid tumors that have stopped responding to other therapies.
What could go wrong: This is an early-phase trial (Phase 1/2) with a small number of participants initially, so results may not apply broadly. Side effects are unknown and could be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 1,438 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified): * Aged ≥18 years at the time of giving informed consent. Local laws will be followed if the age of consent is older. * Have histologic or cytologic documented advanced disease, either at relapse or upon diagnosis of metastatic disease. This requirement may be considered met when advanced disease derives from unequivocal progression of a previously biopsied site of disease (e.g., progression of residual tumor after concomitant chemo-radiation for Stage III NSCLC). * Have measurable disease defined by RECIST v1.1. * Have ECOG performance status of 0 or 1. * Have adequate organ and bone marrow function (as specified in the protocol) within 7 days before randomization/enrollment. * Cohort 1A: * Have histologically or cytologically confirmed diagnosis of unresectable or metastatic cutaneous melanoma not amenable to local therapy. * Participants must have previously received a PD-1 or PD-L1 inhibitor, and, for participants with human gene that encodes a protein called B-Raf (BRAF) gene mutant melanoma, a prior treatment regimen that included vemurafenib, dabrafenib, or another BRAF gene inhibitor with or without mitogen-activated protein kinase protein inhibitor, if available and clinically indicated per local standard of care (SoC) and have experienced progression during or after the previous treatment or discontinued from prior therapy due to intolerance. * Cohort 1B and 1C: Have advanced (i.e., metastatic or locally recurrent where local therapy with curative intent is not possible) non-squamous or squamous NSCLC. * Cohort 1B: * Have no actionable genomic alterations, such as EGFR mutations, anaplastic lymphoma kinase rearrangements, or other genomic alterations for which targeted molecular therapies are available. For enrolled participants with predominantly squamous histology tumors, molecular testing will not be required in cases where it is not part of the SoC. * Have experienced relapse or progression during or after treatment with standard systemic therapy including platinum-based chemotherapy and/or immune checkpoint inhibitor in the advanced/metastatic setting or discontinued from prior therapy due to intolerance. * Participants must have received 1 to 3 lines of systemic treatment in the metastatic setting, which can include anti-PD-1/PD-L1 therapy (if PD-L1 positive), chemotherapy, and anti-angiogenic agents. These treatments may be administered concurrently or sequentially. Prior chemotherapy must be limited to 2 lines or less. * Cohort 1C: * Have documented positive test results for an EGFR-sensitizing mutation (EGFR-sensitizing mutation Exon 21-L858R and 19del). * Participants must have received one or two prior lines of systemic therapy for advanced and/or metastatic disease, which must include treatment with an approved EGFR Tyrosine Kinase Inhibitors (TKI), with at least one being a third-generation EGFR TKI. If there is no third-generation EGFR TKI approved as part of SoC by local health authorities in a certain country, failure/progression on any EGFR TKI is acceptable for eligibility. * Participants receiving an EGFR TKI at the time of signing informed consent may continue to take the EGFR TKI until 5 days prior to Cycle 1 Day 1. * Prior chemotherapy and amivantamab are permitted only if administered in combination with an EGFR TKI as part of a single line of therapy and as the initial (first-line) treatment for advanced/metastatic disease. Participants must not have received any other systemic therapies (such as chemotherapy, immunotherapy, or targeted agents) for advanced/metastatic disease, unless those treatments were given in combination with an EGFR TKI. * Have experienced progression during or after treatment or discontinued from prior therapy due to intolerance. * Cohort 1D: * Have histologically or cytologically confirmed diagnosis of unresectable or metastatic acral/uveal/mucosal melanoma not amenable to local therapy. * Participants must have: * Previously been treated with a PD-1 or PD-L1 inhibitor, if clinically indicated and available per local SoC, and/or * For participants with Human Leukocyte Antigen Alleles (HLA-A)\*02:01 serotype-positive disease (only applicable for uveal melanoma), previously been treated with tebentafusp-tebn if clinically indicated and available per local SoC, and * Experienced progression during or after the previous treatment or discontinued from prior therapy due to intolerance. * Cohorts 1E and 1F (DDI): * Have histologically or cytologically confirmed diagnosis of unresectable or metastatic advanced solid tumor not amenable to ablative or curative approach including, but not limited to: * Cholangiocarcinoma, including tumors of the intra- and extrahepatic biliary tract and gallbladder * Hepatocellular carcinoma (HCC). * Renal cell carcinoma * Endometrial carcinoma, excluding those classified as true sarcomas * Pancreatic ductal adenocarcinoma (PDAC) (see below other related inclusion criterion) * Neuroendocrine tumor of pancreatic, gastrointestinal, lung, and thymus that is well differentiated, Grade 1 to 3. * NSCLC (Cohort 1F only) * Have experienced disease progression on at least one and no more than three lines of prior therapy or, for Cohort 1E only, discontinued from prior therapy due to intolerance. * (For participants with PDAC only) Have received one or two lines of systemic therapy for metastatic tumors, and have experienced progression or intolerance to the treatment during or following therapy. * Cohort 2A: Have histologically or cytologically confirmed diagnosis of unresectable or metastatic cutaneous melanoma not amenable to local therapy. * Cohort 2B: Have histologically or cytologically confirmed diagnosis of recurrent unresectable or metastatic breast cancer that is documented as HER2-negative and either HR-negative or HR-positive per American Society of Clinical Oncology/College of American Pathologists guidelines. * Cohort 2D: * Histologically and/or cytologically documented metastatic adenocarcinoma and squamous carcinoma of GC/GEJC. (Note: Esophageal squamous-cell carcinoma is excluded). * (2L subgroup): Had disease progression during or after one prior line of anti-cancer therapy for recurrent/metastatic disease. * (3L subgroup): Has received two or more lines of prior anti-cancer therapy for recurrent/metastatic disease. * (HER2-expression positive subgroup): Has received at least one prior line of systemic therapy for recurrent or metastatic disease, including a HER2-targeted agent in accordance with local SoC. * Cohort 2E: * Histologically and/or cytologically documented recurrent unresectable metastatic colorectal adenocarcinoma. * Must have received at least one line to a maximum of three lines of prior SoC treatment for recurrent/metastatic disease. * Cohort 1G and 2F: * Histologically and/or cytologically documented recurrent unresectable metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology. * Must have received platinum-based chemotherapy, with or without an anti-PD-(L)1 agent and bevacizumab for metastatic/recurrent disease, unless the patient is not a candidate in the opinion of the treating physician. Key Exclusion Criteria (applicable to all participants and all parts unless otherwise specified): * Have a history of intolerance to treatment with a topoisomerase I inhibitor or intolerance to an ADC that consists of a topoisomerase I inhibitor, including but not limited to topotecan, irinotecan, and deruxtecan (e.g., severe diarrhea). * Have an uncontrolled concomitant or intercurrent illness that contra-indicates study participation, limits compliance with study procedures or substantially increases the risk of incurring adverse events, including: * Bleeding diathesis or active hemorrhage, * Active infection, * Child-Pugh class B or C cirrhosis, * Known pulmonary disease with significant impact in lung function * Oncologic emergencies or complications (e.g., malignant hypercalcemia, superior vena cava syndrome, carcinoid syndrome that is unstable and with available alternative therapies), * Psychiatric or abuse condition * Infectious colitis Grade ≥2 not resolved to Grade 1 within 72 hours within the past 3 months. * Have LVEF \<50% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization/enrollment. * Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization/enrollment. * Have a history of (non-infectious) interstitial lung disease (ILD) /pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. Asymptomatic interstitial changes caused by previous radiation therapy, chemotherapy, or other factors such as smoking are acceptable. * Are a participant of child-bearing potential who are pregnant or breastfeeding or are planning pregnancy within 225 days (\~7.5 months) after receiving last dose of BNT326 and within 6 months after last dose of pumitamig, whichever is longer. * Are potentially fertile males, who are planning to father children during the study or within 135 days (\~4.5 months) after the last dose of BNT326 and within 6 months after last dose of pumitamig, whichever is longer. * Are subject to exclusion periods from another investigational study. * Specific to pumitamig: Participants with significant risks of hemorrhage or evidence of major coagulation disorders as specified in the protocol. * Specific to pumitamig: Have a history of intolerance to treatment with an anti-vascular endothelial growth factor, anti-PD-1/PDL-1, or similar substance, including, but not limited to, bevacizumab, ramucirumab, atezolizumab, pembrolizumab, nivolumab, or other related therapies. * Cohort 1E: Have histological diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Get updates

Get notified about this study

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

acral lentiginous melanoma cervical cancer colorectal cancer cutaneous melanoma gastric cancer gastric neoplasm gastroesophageal junction adenocarcinoma Her2-receptor negative breast cancer lethal congenital contracture syndrome 2 melanoma mucosal melanoma neoplasm non-small cell lung carcinoma uveal melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

76 sites in 9 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Adana City Education and Research Hospital
RECRUITING

Yüreğir, 1320, Turkey (Türkiye)
Ankara Bilkent City Hospital Phase 1 Clinical Research Center
RECRUITING

Ankara, 6800, Turkey (Türkiye)
Austin Health
RECRUITING

Heidelberg, Victoria, 3084, Australia
Beatson West of Scotland Cancer Centre
RECRUITING

Glasgow, G12 0YN, United Kingdom
Blacktown Hospital
RECRUITING

Blacktown, New South Wales, 2148, Australia
Brigitte Harris Cancer Pavilion BHCP
RECRUITING

Detroit, Michigan, 48202, United States
Cancer Research SA
RECRUITING

Adelaide, South Australia, 5000, Australia
Centre hospitalier universitaire de Liège
RECRUITING

Liège, 4000, Belgium
Centro Integral Oncologico Clara Campal
RECRUITING

Madrid, 28050, Spain
Charité - Campus Charité Mitte
NOT_YET_RECRUITING

Berlin, 10117, Germany
Cleveland Clinic Taussig Cancer Center
RECRUITING

Cleveland, Ohio, 44195, United States
Dana Farber Cancer Institute
NOT_YET_RECRUITING

Boston, Massachusetts, 02215, United States
Dr. Abdurrahman Yurtaslan Ankara Oncology Traning & Research
RECRUITING

Ankara, 06200, Turkey (Türkiye)
Duke Cancer Institute
NOT_YET_RECRUITING

Durham, North Carolina, 27710, United States
Emory University
NOT_YET_RECRUITING

Atlanta, Georgia, 30322, United States
Florida Cancer Specialists
RECRUITING

Sarasota, Florida, 34232, United States
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING

Milan, 20133, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING

Roma, 00168, Italy
Hacettepe Oncology Hospital
RECRUITING

Ankara, 6230, Turkey (Türkiye)
Hartford Healthcare
RECRUITING

Hartford, Connecticut, 06102, United States
Hospital Beata Maria Ana
RECRUITING

Madrid, 28007, Spain
Hospital Clinic de Barcelona
NOT_YET_RECRUITING

Barcelona, 08036, Spain
Hospital Clinico San Carlos
RECRUITING

Madrid, 28040, Spain
Hospital Universitari Vall d'Hebron - VHIO
RECRUITING

Barcelona, 08035, Spain
Hospital Universitari i Politecnic La Fe
RECRUITING

Valencia, 46026, Spain
Hospital Universitario Fundacion Jimenez Diaz
RECRUITING

Madrid, 28040, Spain
Hospital Universitario Quironsalud Madrid
RECRUITING

Pozuelo de Alarcón, 28223, Spain
Hospital de San Pedro
RECRUITING

Logroño, 26006, Spain
Hubei Cancer Hospital
NOT_YET_RECRUITING

Wuhan, 430079, China
IEO Istituto Europeo di Oncologia
RECRUITING

Milan, 20141, Italy
IRCCS Ospedale San Raffaele Oncologia Medica
NOT_YET_RECRUITING

Milan, 20132, Italy
Imperial College London
RECRUITING

London, W12 0HS, United Kingdom
Institut Jules Bordet
RECRUITING

Anderlecht, 1070, Belgium
Istituto Clinico Humanitas
RECRUITING

Rozzano, 20089, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
RECRUITING

Naples, 80131, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
RECRUITING

Meldola, 47014, Italy
Klinikum der Universität München Campus Grosshadern
RECRUITING

München, 81377, Germany
Koc University Hospital
RECRUITING

Istanbul, 34010, Turkey (Türkiye)
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02215, United States
Mayo Clinic Arizona
NOT_YET_RECRUITING

Phoenix, Arizona, 85054, United States
Melanoma Institute Australia
RECRUITING

Wollstonecraft, New South Wales, 2065, Australia
Memorial Sloan Kettering Hospital
RECRUITING

New York, New York, 10065, United States
Moffitt Cancer Center
RECRUITING

Tampa, Florida, 33612-9497, United States
Northern Centre for Cancer Care
RECRUITING

Newcastle upon Tyne, NE7 7DN, United Kingdom
One Clinical Research Pty Ltd
RECRUITING

Nedlands, Western Australia, 6009, Australia
Peninsula and South Eastern Haematology & Oncology Group
NOT_YET_RECRUITING

Frankston, Victoria, 3199, Australia
Queen Elizabeth Hospital
RECRUITING

Birmingham, B15 2TH, United Kingdom
Royal Free Hospital
RECRUITING

London, NW3 2QG, United Kingdom
Royal Marsden Hospital
RECRUITING

Sutton, SM2 5PT, United Kingdom
Royal Marsden Hospital-London
RECRUITING

London, SW3 6JJ, United Kingdom
START Barcelona -HM Nou Delfos
RECRUITING

Barcelona, 8023, Spain
START Midwest, LLC
RECRUITING

Grand Rapids, Michigan, 49546, United States
START Mountain Region
RECRUITING

West Valley City, Utah, 84119, United States
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
RECRUITING

Hangzhou, 310009, China
South Texas Accelerated Research Therapeutics (START), LLC
RECRUITING

San Antonio, Texas, 78229, United States
Southampton General Hospital
RECRUITING

Southampton, SO16 6YD, United Kingdom
St Vincent's Hospital Sydney
RECRUITING

Darlinghurst, New South Wales, 2010, Australia
Tasman Oncology Research Ltd
RECRUITING

Southport, Queensland, 4215, Australia
The Alfred Hospital
RECRUITING

Melbourne, Victoria, 3004, Australia
The Board of Regents of the University of Wisconsin
RECRUITING

Madison, Wisconsin, 53792-6188, United States
The Christie Hospital
RECRUITING

Manchester, M20 4BX, United Kingdom
The Clatterbridge Cancer Centre
RECRUITING

Liverpool, L7 8YA, United Kingdom
The Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING

Hangzhou, 310017, China
The University of Texas MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States
Tianjin Medical University Cancer Institute & Hospital
RECRUITING

Tianjin, 300451, China
Universitaetsklinikum Essen
RECRUITING

Essen, 45147, Germany
Universitair Ziekenhuis Gent
RECRUITING

Ghent, 9000, Belgium
University College London Hospitals
RECRUITING

London, W1T 7HA, United Kingdom
University of California San Francisco
NOT_YET_RECRUITING

San Francisco, California, 94158, United States
University of Pittsburgh Medical Center
RECRUITING

Pittsburgh, Pennsylvania, 15232, United States
Universitätsklinikum Tübingen
RECRUITING

Tübingen, 72076, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
RECRUITING

Mainz, 55131, Germany
Velindre Cancer Centre
RECRUITING

Cardiff, CF14 2TL, United Kingdom
Yale University
RECRUITING

New Haven, Connecticut, 06511, United States
Yeditepe University Kosuyolu Hospital
NOT_YET_RECRUITING

Istanbul, 34718, Turkey (Türkiye)
Ziekenhuis Aan de Stroom ZAS vzw
RECRUITING

Wilrijk, 2610, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.