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 (12) 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
California
Precision NextGen Oncology and Research Center
RECRUITING
Beverly Hills
New Jersey
John Theurer Cancer Center at Hackensack UMC
RECRUITING
Hackensack
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Other Locations
Australia
Sunshine Hospital
RECRUITING
Saint Albans
China
Guangxi Medical University Cancer Hospital
RECRUITING
Nanning
Linyi Cancer Hospital
RECRUITING
Shandong
Xiangyang Central Hospital
RECRUITING
Xiangyang
Turkey
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
RECRUITING
Ankara
Hacettepe University Medical Faculty
RECRUITING
Ankara
Yeditepe University Medical School Hospital
RECRUITING
Istanbul
United Kingdom
Bristol Haematology and Oncology Centre
RECRUITING
Bristol
University College London Hospital
RECRUITING
London
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