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
Status: Recruiting
Location: See all (76) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This study aims to investigate the combination of BNT324, a B7-H3 antibody-drug conjugate (ADC) with BNT327, a programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF) bispecific antibody, in participants with advanced/metastatic or relapsed/progressive small cell lung cancer (SCLC) and non small cell lung cancer (NSCLC).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Aged ≥18 years at the time of giving informed consent.
• Histological or cytological confirmed unresectable advanced/metastatic lung cancer. Histological classification may be based on tumor samples prior to metastatic disease. Participants with mixed histology must be classified based on the main component. Participants with NSCLC are eligible with any or no PD-L1 expression. Participants with AGA-positive disease must have received targeted therapy prior to enrollment in this study.
‣ Part 1: Participants with NSCLC and SCLC
⁃ Part 2 Cohort 1: Participants with NSCLC (subpopulation 1) AGA negative, 1L
⁃ Part 2 Cohort 2: Participants with SCLC, 2L+
⁃ Part 2 Cohort 3: Participants with NSCLC (subpopulation 1) AGA negative, 2L+
⁃ Part 2 Cohort 6: Participants with NSCLC AGA positive
⁃ Part 2 Cohort 7: Participants with SCLC, 1L
• Have measurable disease defined by RECIST version 1.1.
• Have an Eastern Cooperative Oncology Group performance status of 0 or 1.
• Have a life expectancy of ≥12 weeks.
Locations
United States
Arizona
Mayo Clinic Arizona
RECRUITING
Phoenix
California
Precision NextGen Oncology and Research Center
RECRUITING
Beverly Hills
Cedars Sinai Medical Center
RECRUITING
Los Angeles
UCLA - David Geffen School of Medicine
RECRUITING
Santa Monica
Colorado
University of Colorado Cancer Center
RECRUITING
Aurora
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Iowa
University of Iowa Hospitals & Clinics PARENT
RECRUITING
Iowa City
Minnesota
Mayo Clinic-Rochester
RECRUITING
Rochester
New Jersey
John Theurer Cancer Center at Hackensack UMC
RECRUITING
Hackensack
New York
Icahn School of Medicine at Mount Sinai PRIME
RECRUITING
New York
Memorial Sloan Kettering Cancer Center (MSKCC)
RECRUITING
New York
Ohio
Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center
RECRUITING
Cleveland
Texas
Texas Oncology - DFW
RECRUITING
Dallas
MD Anderson Cancer Center
RECRUITING
Houston
Texas Oncology - Northeast
RECRUITING
Tyler
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Other Locations
Australia
Flinders Medical Centre
RECRUITING
Bedford Park
Bendigo Hospital
RECRUITING
Bendigo
Chris O'Brien Lifehouse
RECRUITING
Camperdown
Barwon Health
RECRUITING
Geelong
Sunshine Hospital
RECRUITING
Saint Albans
St John of God Subiaco Hospital
RECRUITING
Subiaco
China
Beijing Cancer Hospital
RECRUITING
Beijing
Beijing GoBroad Hospital
RECRUITING
Beijing
Jilin Cancer Hospital
RECRUITING
Changchun
Hunan Province People's Hospital
RECRUITING
Changsha
West China Hospital, Sichuan University
RECRUITING
Chengdu
Fujian Cancer Hospital
RECRUITING
Fuzhou
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
RECRUITING
Hangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Anhui Provincial Cancer Hospital
RECRUITING
Hefei
Jinan Central Hospital
RECRUITING
Jinan
Shandong Cancer Hospital
RECRUITING
Jinan
Jingzhou First People's Hospital
RECRUITING
Jingzhou
Jiangxi Cancer Hospital
RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Nanjing Chest Hospital
RECRUITING
Nanjing
Guangxi Medical University Cancer Hospital
RECRUITING
Nanning
Linyi Cancer Hospital
RECRUITING
Shandong
Shanghai GoBroad Cancer Hospital
RECRUITING
Shanghai
The First Affiliated Hospital of Xinxiang Medical University
RECRUITING
Weihui
The First Affiliated Hospital of Xian Jiaotong University
RECRUITING
Xi'an
Xiangyang Central Hospital
RECRUITING
Xiangyang
Yichang Central People's Hospital
RECRUITING
Yichang
Henan Provincial Cancer Hospital
RECRUITING
Zhengzhou
France
Assistance Publique-Hôpitaux de Marseille
RECRUITING
Marseille
Hôpital Foch
RECRUITING
Suresnes
Italy
IRCCS Istituto di Candiolo
RECRUITING
Candiolo
Poland
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Pratia Onkologia Katowice
RECRUITING
Katowice
Centrum Medyczne Pratia Poznań
RECRUITING
Poznan
Spain
Clinica Universidad de Navarra
RECRUITING
Barcelona
Hospital Universitari Dexeus
RECRUITING
Barcelona
Hospital Universitario Nuestra Señora de Valme
RECRUITING
Seville
Hospital Universitario de Torrejón
RECRUITING
Torrejón De Ardoz
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Taichung Veterans General Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan
National Taiwan University Cancer Center
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Turkey
Adana City Hospital
RECRUITING
Adana
Ankara City Hospital
RECRUITING
Ankara
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
RECRUITING
Ankara
Hacettepe University Medical Faculty
RECRUITING
Ankara
Koc University Hospital
RECRUITING
Istanbul
Yeditepe University Medical School Hospital
RECRUITING
Istanbul
Sakarya Training and Research Hospital
RECRUITING
Sakarya
United Kingdom
Bristol Haematology and Oncology Centre
RECRUITING
Bristol
St. James's University Hospital
RECRUITING
Leeds
The Clatterbridge Cancer Center
RECRUITING
Liverpool
St George's Hospitals NHS Foundation Trust
RECRUITING
London
University College London Hospital
RECRUITING
London
The Christie NHS Foundation Trust
RECRUITING
Manchester
Contact Information
Primary
BioNTech clinical trials patient information
patients@biontech.de
+49 6131 9084
Time Frame
Start Date: 2025-05-02
Estimated Completion Date: 2031-06
Participants
Target number of participants: 594
Treatments
Experimental: Part 1 - BNT324 + BNT327 combination therapy
Escalating combination dose levels of BNT324 and BNT327 to define RP2D and RP2D-1 for NSCLC and SCLC.
Experimental: Part 2 - Cohort 1: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327
In subpopulation 1 of NSCLC actionable oncogenic alteration (AGA) negative, first-line (1L)
Experimental: Part 2 - Cohort 2: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327
In SCLC, second-line plus (2L+)
Experimental: Part 2 - Cohort 3: RP2D of BNT324 + BNT327
In subpopulation 1 of NSCLC AGA negative, 2L+
Experimental: Part 2 - Cohort 4: RP2D of BNT324 + BNT327
In subpopulation 2 of NSCLC AGA negative, 1L
Experimental: Part 2 - Cohort 5: RP2D of BNT324 + BNT327
In subpopulation 2 of NSCLC AGA negative, 2L+
Experimental: Part 2 - Cohort 6: RP2D of BNT324 + BNT327
In NSCLC AGA positive
Experimental: Part 2 - Cohort 7: RP2D of BNT324 + BNT327
In SCLC, 1L
Related Therapeutic Areas
Sponsors
Collaborators: DualityBio Inc., Biotheus Inc.
Leads: BioNTech SE