A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer
Sponsored by BioNTech SE
About this study
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).
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…
Where this study is enrolling (2)
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Mayo Clinic Arizona
Phoenix, Arizona
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MD Anderson Cancer Center
Houston, Texas
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Who can participate
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.
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Trial data sourced from ClinicalTrials.gov.