A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer
Recruiting · NCT06892548 · Interventional (participants receive a specific treatment) · Lead sponsor: BioNTech SE
View the official record on ClinicalTrials.gov →Interventions studied
BNT324BNT327
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 4: Participants with NSCLC (subpopulation 2) AGA negative, 1L
- Part 2 Cohort 5: Participants with NSCLC (subpopulation 2) 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.
Exclusion criteria
- Prior treatment with B7-H3 targeted therapy.
- Prior treatment with ADC with topoisomerase inhibitor (e.g., datopotamab deruxtecan, trastuzumab deruxtecan). Note: This exclusion applies to participants in the first-line/treatment-naïve cohorts in the advanced/metastatic setting. Prior treatment with ADC with topoisomerase inhibitor payload is only allowed for participants in the second-line plus cohorts in the advanced/metastatic setting.
- Is a candidate to locoregional treatment (including surgical resection, stereotactic radiotherapy or tumor ablation) with potential to induce complete or near complete response and prolonged tumor control (sometimes described as "radical" intent), per investigator's assessment.
- Has a history of significant hematologic toxicity to prior lines of therapy, as assessed by investigator, e.g., Grade 4 febrile neutropenia or recurrent/persistent Grade 3 to 4 neutropenia.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply to all or some participants depending on the cohort.
Where it is running
60 locations listed across 11 US states.
- Mayo Clinic Arizona - Phoenix, Arizona, United States
- Precision NextGen Oncology and Research Center - Beverly Hills, California, United States
- Cedars Sinai Medical Center - Los Angeles, California, United States
- UCLA - David Geffen School of Medicine - Santa Monica, California, United States
- University of Colorado Cancer Center - Aurora, Colorado, United States
- Mayo Clinic in Florida - Jacksonville, Florida, United States
- University of Iowa Hospitals & Clinics PARENT - Iowa City, Iowa, United States
- Mayo Clinic-Rochester - Rochester, Minnesota, United States
- Regional Cancer Care Associates - Belleville, New Jersey, United States
- John Theurer Cancer Center at Hackensack UMC - Hackensack, New Jersey, United States
- Memorial Sloan Kettering Cancer Center (MSKCC) - New York, New York, United States
- Icahn School of Medicine at Mount Sinai PRIME - New York, New York, United States
- Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center - Cleveland, Ohio, United States
- Texas Oncology - DFW - Dallas, Texas, United States
- MD Anderson Cancer Center - Houston, Texas, United States
- Texas Oncology - Northeast - Tyler, Texas, United States
- Virginia Cancer Specialists - Fairfax, Virginia, United States
- Adana City Hospital - Adana, Turkey (Türkiye)
- Hacettepe University Medical Faculty - Ankara, Turkey (Türkiye)
- Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital - Ankara, Turkey (Türkiye)
- Ankara City Hospital - Ankara, Turkey (Türkiye)
- Hospital Universitari Dexeus - Barcelona, Spain
- Clinica Universidad de Navarra - Barcelona, Spain
- Hospital Universitari Vall d'Hebron - Barcelona, Spain
- Bristol Haematology and Oncology Centre - Bristol, United Kingdom
- IRCCS Istituto di Candiolo - Candiolo, Italy
- Centre Hospitalier Intercommunal de Créteil - Créteil, France
- Hospital Universitario Reina Sofia - Córdoba, Spain
- The First Affiliated Hospital of Xiamen University - Fujian, China
- Uniwersyteckie Centrum Kliniczne - Gdansk, Poland
- Affiliated Cancer Hospital and Institute of Guangzhou Medical University - Guandong, China
- Yeditepe University Medical School Hospital - Istanbul, Turkey (Türkiye)
- Koc University Hospital - Istanbul, Turkey (Türkiye)
- Kaohsiung Medical University Chung-Ho Memorial Hospital - Kaohsiung City, Taiwan
- Pratia Onkologia Katowice - Katowice, Poland
- St. James's University Hospital - Leeds, United Kingdom
- The Clatterbridge Cancer Center - Liverpool, United Kingdom
- St George's Hospitals NHS Foundation Trust - London, United Kingdom
- University College London Hospital - London, United Kingdom
- The Christie NHS Foundation Trust - Manchester, United Kingdom
- Assistance Publique-Hôpitaux de Marseille - Marseille, France
- IRCCS Ospedale San Raffaele - Milan, Italy
- Hospital Quironsalud Malaga - Málaga, Spain
- Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Naples, Italy
- Centrum Medyczne Pratia Poznań - Poznan, Poland
- Royal Preston Hospital - Preston, United Kingdom
- Istituto Nazionale Tumori Regina Elena IRCCS - Roma, Italy
- Sakarya Training and Research Hospital - Sakarya, Turkey (Türkiye)
- Hospital Universitario Nuestra Señora de Valme - Seville, Spain
- Hôpital Foch - Suresnes, France
- Taichung Veterans General Hospital - Taichung, Taiwan
- National Cheng Kung University Hospital - Tainan, Taiwan
- National Taiwan University Cancer Center - Taipei, Taiwan
- Taipei Veterans General Hospital - Taipei, Taiwan
- Hospital Universitario de Torrejón - Torrejón de Ardoz, Spain
- Hopital Larrey - Toulouse, France
- Hospital Universitari i Politecnic La Fe - Valencia, Spain
- Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - Verona, Italy
- Xuzhou Central Hospital - Xuzhou, China
- Anhui Provincial Cancer Hospital - Hefei, Anhui, China
Showing 60 of 91 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →