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).
Additional locations may be listed on ClinicalTrials.gov for NCT06892548.
Locations matching your search criteria
United States
New Jersey
Hackensack
Hackensack University Medical CenterStatus: Active
Name Not Available
This is a two-part study designed to evaluate and establish two safe combination dose
levels (recommended Phase 2 dose [RP2D] and a lower/another combination dose level
[RP2D-1]) of BNT324 with BNT327 (Part 1), to determine the optimal combination dose (dose
optimization [DO]) in NSCLC and SCLC lead indication cohorts at the RP2D and RP2D-1, to
evaluate the preliminary efficacy in selected lung cancer cohorts at the highest
combination dose level (in a signal seeking Part 2), and to confirm the clinical efficacy
of BNT324 in combination with BNT327 at the optimal dose level in participants with
advanced lung cancer in expansion cohorts (proof-of-concept [POC] cohorts).
The study consists of a screening period, a treatment period, a safety follow-up period,
and a long-term survival follow-up period.
In Part 1 participants with histologically or cytologically confirmed relapsed or
progressive lung cancer (both SCLC and NSCLC are eligible) will receive BNT324 in
combination with BNT327 using a dose escalation design.
In Part 2 of the study, BNT324 will be studied in combination with BNT327 at the RP2D
compared to RP2D-1 in participants with advanced metastatic treatment-naïve NSCLC (DO
Cohort 1) and relapsed/progressive SCLC after failure of cytotoxic chemotherapy with or
without immuno-oncology (IO) (DO Cohort 2). The totality of the available data (e.g.,
safety, efficacy, pharmacokinetics etc.) will be reviewed to select the optimal dose.
After the optimal dose is selected, additional participants in each cohort may be
enrolled in the selected optimal dose.
In the signal seeking cohorts (Cohort 3-7), participants will receive BNT324 in
combination with BNT327 at the RP2D from Part 1.
A predefined number of participants in Part 2 Cohort 1 and Cohort 2 will be randomized to
one of the two dose levels (RP2D and RP2D-1) selected from Part 1 in a 1:1 ratio.
Additional participants in Part 2 Cohort 1 and Cohort 2 may be enrolled in the selected
optimal dose to further assess the efficacy and safety profile.
No randomization is planned for any other cohort in Part 2 or Part 1.
Lead OrganizationBiontech SE
