Actively Recruiting
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
Led by BioNTech SE · Updated on 2026-03-12
980
Participants Needed
53
Research Sites
215 weeks
Total Duration
On this page
Sponsors
B
BioNTech SE
Lead Sponsor
B
BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older at the time of consent
- Have histologic or cytologic confirmed advanced disease, either relapsed or metastatic
- Have measurable disease based on RECIST v1.1 criteria
- Provide tumor tissue sample from archival tissue or new biopsy
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have adequate organ and bone marrow function within 7 days before enrollment
- Specific cancer diagnoses and prior treatment histories as defined for each cohort (e.g., unresectable metastatic cutaneous melanoma, non-small cell lung cancer with or without genomic alterations, breast cancer HER2-negative, gastric cancer, colorectal cancer, cervical cancer)
- Have experienced progression or intolerance after prior therapies as specified per cohort
You will not qualify if you...
- History of intolerance to topoisomerase I inhibitors or antibody-drug conjugates containing them
- Uncontrolled illnesses that increase risk or limit compliance, including bleeding disorders, active infections, severe liver cirrhosis, lung disease impacting function, oncologic emergencies, psychiatric or substance abuse conditions, severe infectious colitis
- Left ventricular ejection fraction below 50% within 28 days before enrollment
- Uncontrolled pleural effusion, ascites, or pericardial effusion needing drainage within 2 weeks before enrollment
- History or current interstitial lung disease or pneumonitis requiring steroids
- Pregnant or breastfeeding females or planning pregnancy within 7.5 months after last BNT326 dose or 6 months after last BNT327 dose
- Fertile males planning to father children during study or within 4.5 months after last BNT326 dose or 6 months after last BNT327 dose
- Subject to exclusion periods from other investigational studies
- For BNT327: significant bleeding risk or major coagulation disorders
- History of intolerance to anti-VEGF or checkpoint inhibitor therapies
- Specific histological exclusions such as fibrolamellar hepatocellular carcinoma or sarcomatoid HCC for Cohort 1E
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 53 locations
1
University of California San Francisco
San Francisco, California, United States, 94158
Not Yet Recruiting
2
Hartford Healthcare
Hartford, Connecticut, United States, 06102
Actively Recruiting
3
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
4
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
5
Moffitt Cancer Center
Tampa, Florida, United States, 33612-9497
Actively Recruiting
6
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
7
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
8
START Midwest, LLC
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
9
Memorial Sloan Kettering Hospital
New York, New York, United States, 10065
Actively Recruiting
10
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Not Yet Recruiting
11
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
12
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
13
South Texas Accelerated Research Therapeutics (START), LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
14
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
15
The Board of Regents of the University of Wisconsin
Madison, Wisconsin, United States, 53792-6188
Actively Recruiting
16
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
Actively Recruiting
17
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
18
Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia, 2065
Actively Recruiting
19
Tasman Oncology Research Ltd
Southport, Queensland, Australia, 4215
Actively Recruiting
20
Cancer Research SA
Adelaide, South Australia, Australia, 5000
Actively Recruiting
21
Austin Health
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
22
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
23
One Clinical Research Pty Ltd
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
24
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
25
Centre hospitalier universitaire de Liège
Liège, Belgium, 4000
Actively Recruiting
26
Ziekenhuis Aan de Stroom ZAS vzw
Wilrijk, Belgium, 2610
Actively Recruiting
27
Charité - Campus Charité Mitte
Berlin, Germany, 10117
Not Yet Recruiting
28
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
Not Yet Recruiting
29
Klinikum der Universität München Campus Grosshadern
München, Germany, 81377
Not Yet Recruiting
30
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Not Yet Recruiting
31
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Not Yet Recruiting
32
IEO Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
33
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Italy, 80131
Actively Recruiting
34
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
35
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
36
Hospital Universitari Vall d'Hebron - VHIO
Barcelona, Spain, 08035
Actively Recruiting
37
Hospital Beata Maria Ana
Madrid, Spain, 28007
Actively Recruiting
38
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
39
Centro Integral Oncologico Clara Campal
Madrid, Spain, 28050
Actively Recruiting
40
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Spain, 28223
Actively Recruiting
41
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
42
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
43
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
44
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
45
The Clatterbridge Cancer Centre
Liverpool, United Kingdom, L7 8YA
Actively Recruiting
46
Royal Free Hospital
London, United Kingdom, NW3 2QG
Actively Recruiting
47
Royal Marsden Hospital-London
London, United Kingdom, SW3 6JJ
Actively Recruiting
48
Imperial College London
London, United Kingdom, W12 0HS
Actively Recruiting
49
University College London Hospitals
London, United Kingdom, W1T 7HA
Actively Recruiting
50
The Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
51
Northern Centre for Cancer Care
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
52
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
53
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
16
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