Actively Recruiting
A Phase Ib/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Recommended Combination Dose of BNT324 With BNT327 in Participants With Advanced Lung Cancer
Led by BioNTech SE · Updated on 2026-05-19
594
Participants Needed
76
Research Sites
200 weeks
Total Duration
On this page
Sponsors
B
BioNTech SE
Lead Sponsor
D
DualityBio Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the combination of two investigational drugs, BNT324 and BNT327, in people with advanced or metastatic lung cancer, including both small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). This study aims to find safe and effective dose levels, optimize dosing, and evaluate preliminary and clinical efficacy in several lung cancer groups. Participants have advanced or relapsed lung cancer and the trial includes different treatment cohorts based on cancer subtype and previous therapies. The study has two parts: Part 1 tests escalating doses of BNT324 combined with BNT327 to establish two recommended dose levels. In Part 2, participants with specific lung cancer types receive one of these two dose levels to determine the optimal dose. Additional participants may be enrolled to further assess safety and efficacy at this dose. The trial includes both randomized and non-randomized cohorts, with treatments given as intravenous infusions. Participants undergo a screening period before treatment, followed by treatment, safety follow-up, and long-term survival monitoring lasting up to about seven years. Researchers will evaluate safety by tracking side effects and dose modifications, and measure treatment response using objective response rates and other cancer progression markers. Regular assessments include physical exams, imaging, and laboratory tests to monitor health and treatment effects throughout the study.
CONDITIONS
Brief Title
A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of informed consent
- Confirmed unresectable advanced or metastatic lung cancer by histology or cytology
- Participants with NSCLC eligible regardless of PD-L1 expression
- Participants with AGA-positive disease must have had targeted therapy before enrolling
- Measurable disease per RECIST version 1.1
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Prior treatment with B7-H3 targeted therapy
- Prior treatment with antibody-drug conjugates containing topoisomerase inhibitors for first-line advanced/metastatic cohorts
- Candidates for locoregional treatments aimed at complete or near complete tumor control
- History of significant blood-related toxicity from previous therapies, such as severe neutropenia or febrile neutropenia
- Additional protocol-specific criteria may apply depending on cohort
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 87 months from the first dose of investigational medicinal product
Participants receive combination therapy with BNT324 and BNT327 at varying dose levels to evaluate safety and efficacy.
Visit schedule varies depending on cohort and dose level
Duration - 90 days after last dose or until new anticancer therapy starts, whichever occurs first
Participants are monitored for treatment-emergent adverse events and safety after the last dose of therapy.
Approximately 1 to multiple visits depending on participant status
Duration - Up to 87 months from the first dose of investigational medicinal product
Participants are followed to assess long-term outcomes such as overall survival and duration of response.
Visit schedule varies; may include periodic assessments
Trial Site Locations
Total: 76 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 13400
Actively Recruiting
2
Precision NextGen Oncology and Research Center
Beverly Hills, California, United States, 90212
Actively Recruiting
3
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
4
UCLA - David Geffen School of Medicine
Santa Monica, California, United States, 90404
Actively Recruiting
5
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
6
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
7
University of Iowa Hospitals & Clinics PARENT
Iowa City, Iowa, United States, 52242
Actively Recruiting
8
Mayo Clinic-Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
9
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States, 07601
Actively Recruiting
10
Memorial Sloan Kettering Cancer Center (MSKCC)
New York, New York, United States, 10021
Actively Recruiting
11
Icahn School of Medicine at Mount Sinai PRIME
New York, New York, United States, 10029
Actively Recruiting
12
Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Actively Recruiting
13
Texas Oncology - DFW
Dallas, Texas, United States, 75246
Actively Recruiting
14
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
15
Texas Oncology - Northeast
Tyler, Texas, United States, 75702
Actively Recruiting
16
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
17
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
18
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
19
Bendigo Hospital
Bendigo, Victoria, Australia, 3550
Actively Recruiting
20
Barwon Health
Geelong, Victoria, Australia, 3220
Actively Recruiting
21
Sunshine Hospital
Saint Albans, Victoria, Australia, 3021
Actively Recruiting
22
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia, 6008
Actively Recruiting
23
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230088
Actively Recruiting
24
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
25
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102200
Actively Recruiting
26
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
27
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
28
Guangxi Medical University Cancer Hospital
Nanning, Guangxi Zhuang, China, 530021
Actively Recruiting
29
The First Affiliated Hospital of Xinxiang Medical University
Weihui, Henan, China, 453100
Actively Recruiting
30
Henan Provincial Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
31
Jingzhou First People's Hospital
Jingzhou, Hubei, China, 434000
Actively Recruiting
32
Xiangyang Central Hospital
Xiangyang, Hubei, China, 441021
Actively Recruiting
33
Yichang Central People's Hospital
Yichang, Hubei, China, 443000
Actively Recruiting
34
Hunan Province People's Hospital
Changsha, Hunan, China, 410005
Actively Recruiting
35
Nanjing Chest Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
36
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
37
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330209
Actively Recruiting
38
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330209
Actively Recruiting
39
Jilin Cancer Hospital
Changchun, Jilin, China, 130000
Actively Recruiting
40
Linyi Cancer Hospital
Shandong, Linyi, China, 276001
Actively Recruiting
41
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
42
Jinan Central Hospital
Jinan, Shandong, China, 250013
Actively Recruiting
43
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
44
Shanghai GoBroad Cancer Hospital
Shanghai, Shanghai Municipality, China, 200125
Actively Recruiting
45
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 611100
Actively Recruiting
46
First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
47
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China, 310016
Actively Recruiting
48
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
49
Assistance Publique-Hôpitaux de Marseille
Marseille, France, 13005
Actively Recruiting
50
Hôpital Foch
Suresnes, France, 92151
Actively Recruiting
51
IRCCS Istituto di Candiolo
Candiolo, Italy, 10060
Actively Recruiting
52
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-214
Actively Recruiting
53
Pratia Onkologia Katowice
Katowice, Poland, 40-519
Actively Recruiting
54
Centrum Medyczne Pratia Poznań
Poznan, Poland, 60-192
Actively Recruiting
55
Hospital Universitari Dexeus
Barcelona, Spain, 08028
Actively Recruiting
56
Clinica Universidad de Navarra
Barcelona, Spain, 08036
Actively Recruiting
57
Hospital Universitario Nuestra Señora de Valme
Seville, Spain, 41014
Actively Recruiting
58
Hospital Universitario de Torrejón
Torrejón de Ardoz, Spain, 28850
Actively Recruiting
59
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Actively Recruiting
60
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
61
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
62
National Taiwan University Cancer Center
Taipei, Taiwan, 106
Actively Recruiting
63
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
64
Adana City Hospital
Adana, Turkey (Türkiye), 01230
Actively Recruiting
65
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye), 06100
Actively Recruiting
66
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
Ankara, Turkey (Türkiye), 06105
Actively Recruiting
67
Ankara City Hospital
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
68
Yeditepe University Medical School Hospital
Istanbul, Turkey (Türkiye), 31755
Actively Recruiting
69
Koc University Hospital
Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
70
Sakarya Training and Research Hospital
Sakarya, Turkey (Türkiye), 54187
Actively Recruiting
71
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
72
St. James's University Hospital
Leeds, United Kingdom, LS97TF
Actively Recruiting
73
The Clatterbridge Cancer Center
Liverpool, United Kingdom, L7 8YA
Actively Recruiting
74
St George's Hospitals NHS Foundation Trust
London, United Kingdom, SW170QT
Actively Recruiting
75
University College London Hospital
London, United Kingdom, W1T 7HA
Actively Recruiting
76
The Christie NHS Foundation Trust
Manchester, United Kingdom, M204BX
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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