Actively Recruiting
A Phase I/II, Open-label, Adaptive Two-part Trial to Evaluate the Safety, Efficacy, Optimal Dose and Pharmacokinetics of BNT326 as Monotherapy and in Combination With Cancer Immunotherapies in Participants With Advanced Solid Tumors
Led by BioNTech SE · Updated on 2026-05-22
980
Participants Needed
64
Research Sites
86 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
Researchers are evaluating the safety, effectiveness, best dose, and how the body processes BNT326 when used alone or combined with other immunotherapy drugs in adults with advanced solid tumors. These tumors are either metastatic, recurrent without further treatment options, or have relapsed after previous therapy. The study includes patients with different types of advanced cancers such as melanoma, lung cancer, breast cancer, gastric cancer, colorectal cancer, and cervical cancer. In Part 1, participants receive BNT326 alone across several cancer-specific groups, including cutaneous melanoma, non-small cell lung cancer (with or without specific mutations), rare melanomas, advanced tumors, and cervical cancer. Part 2 evaluates BNT326 alone or combined with another immunotherapy drug called pumitamig. Participants are assigned to different dose levels, sometimes randomly, depending on their cancer type and group. The study includes a screening period, treatment for up to 24 months or until progression or other reasons, and follow-up periods. During the study, participants undergo assessments including tumor tissue sampling, monitoring of treatment side effects, blood tests to measure drug levels, and evaluations of tumor response and survival. Safety is closely followed up to 42 or 90 days after treatment ends, with longer-term monitoring for up to 38 months (Part 1) or 48 months (Part 2). Participants' overall response rates, adverse events, and pharmacokinetics are key outcomes. The study is sponsored by BioNTech SE and includes open-label, adaptive design across two phases.
CONDITIONS
Brief 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 histologically or cytologically confirmed advanced or metastatic solid tumors that have relapsed or progressed
- Have measurable disease by RECIST v1.1 criteria
- Provide a tumor tissue sample from current or archival tumor
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have adequate organ and bone marrow function within 7 days before enrollment
- Meet specific cancer type criteria for each cohort, including prior treatments and mutation status as applicable
You will not qualify if you...
- History of intolerance to topoisomerase I inhibitors or antibody-drug conjugates containing such agents
- Uncontrolled illnesses that increase risk or limit study compliance, including active infection, bleeding disorders, certain lung diseases, oncologic emergencies, psychiatric or substance abuse conditions
- Left ventricular ejection fraction (LVEF) below 50% within 28 days before enrollment
- Clinically uncontrolled pleural, pericardial, or abdominal fluid requiring intervention within 2 weeks before enrollment
- History or current interstitial lung disease or pneumonitis requiring steroids or suspected cases not ruled out by imaging
- Pregnancy, breastfeeding, or planning pregnancy within defined safety periods after last dose
- Fertile males planning to father children within defined safety periods after last dose
- Participation in other investigational studies with exclusion periods
- Specific exclusions related to BNT327, including bleeding risks and intolerance to similar agents
- Certain histological diagnoses excluded in specific cohorts (e.g., fibrolamellar hepatocellular carcinoma)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive BNT326 alone or in combination with other investigational treatments such as pumitamig, itraconazole, or paroxetine. Treatment is given by intravenous infusion or oral administration depending on the drug. Treatment continues for up to 24 months or until disease progression, withdrawal, unacceptable toxicity, or study termination.
Visits for drug administration and monitoring as per protocol, frequency varies by cohort and treatment arm
Duration - Approximately 42 to 90 days
Participants are monitored for safety, including adverse events and pharmacokinetics, for a period following the last dose of treatment to ensure any side effects are captured.
Several visits for safety monitoring post-treatment
Duration - Up to approximately 38 months for Part 1 and 48 months for Part 2
Participants are followed to assess treatment efficacy outcomes such as overall response, disease control, and survival.
Periodic visits to assess tumor response and clinical status
Duration - Up to approximately 48 months total
Participants continue to be followed for long-term survival and overall health outcomes beyond the efficacy assessment period.
Intermittent visits for survival status updates
Trial Site Locations
Total: 64 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Not Yet Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94158
Not Yet Recruiting
3
Hartford Healthcare
Hartford, Connecticut, United States, 06102
Actively Recruiting
4
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
5
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
6
Moffitt Cancer Center
Tampa, Florida, United States, 33612-9497
Actively Recruiting
7
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
8
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
9
Brigitte Harris Cancer Pavilion BHCP
Detroit, Michigan, United States, 48202
Not Yet Recruiting
10
START Midwest, LLC
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
11
Memorial Sloan Kettering Hospital
New York, New York, United States, 10065
Actively Recruiting
12
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Not Yet Recruiting
13
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Actively Recruiting
14
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
15
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
16
South Texas Accelerated Research Therapeutics (START), LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
17
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
18
The Board of Regents of the University of Wisconsin
Madison, Wisconsin, United States, 53792-6188
Actively Recruiting
19
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
Actively Recruiting
20
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
21
Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia, 2065
Actively Recruiting
22
Tasman Oncology Research Ltd
Southport, Queensland, Australia, 4215
Actively Recruiting
23
Cancer Research SA
Adelaide, South Australia, Australia, 5000
Actively Recruiting
24
Austin Health
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
25
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
26
One Clinical Research Pty Ltd
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
27
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
28
Centre hospitalier universitaire de Liège
Liège, Belgium, 4000
Actively Recruiting
29
Ziekenhuis Aan de Stroom ZAS vzw
Wilrijk, Belgium, 2610
Actively Recruiting
30
Charité - Campus Charité Mitte
Berlin, Germany, 10117
Not Yet Recruiting
31
Universitaetsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
32
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
Actively Recruiting
33
Klinikum der Universität München Campus Grosshadern
München, Germany, 81377
Not Yet Recruiting
34
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Actively Recruiting
35
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola, Italy, 47014
Not Yet Recruiting
36
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
37
IEO Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
38
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Italy, 80131
Actively Recruiting
39
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
40
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
41
Hospital Universitari Vall d'Hebron - VHIO
Barcelona, Spain, 08035
Actively Recruiting
42
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Not Yet Recruiting
43
START Barcelona -HM Nou Delfos
Barcelona, Spain, 8023
Actively Recruiting
44
Hospital de San Pedro
Logroño, Spain, 26006
Not Yet Recruiting
45
Hospital Beata Maria Ana
Madrid, Spain, 28007
Actively Recruiting
46
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
47
Centro Integral Oncologico Clara Campal
Madrid, Spain, 28050
Actively Recruiting
48
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Spain, 28223
Actively Recruiting
49
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
50
Dr. Abdurrahman Yurtaslan Ankara Oncology Traning & Research
Ankara, Turkey (Türkiye), 6200
Not Yet Recruiting
51
Hacettepe Oncology Hospital
Ankara, Turkey (Türkiye), 6230
Not Yet Recruiting
52
Yeditepe University Kosuyolu Hospital
Istanbul, Turkey (Türkiye), 34718
Not Yet Recruiting
53
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
54
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
55
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
56
The Clatterbridge Cancer Centre
Liverpool, United Kingdom, L7 8YA
Actively Recruiting
57
Royal Free Hospital
London, United Kingdom, NW3 2QG
Actively Recruiting
58
Royal Marsden Hospital-London
London, United Kingdom, SW3 6JJ
Actively Recruiting
59
Imperial College London
London, United Kingdom, W12 0HS
Actively Recruiting
60
University College London Hospitals
London, United Kingdom, W1T 7HA
Actively Recruiting
61
The Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
62
Northern Centre for Cancer Care
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
63
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
64
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
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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