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A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer

ConditionAdvanced Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioNTech SE

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BNT324

    Biological/Vaccine

    Intravenous infusion

  • BNT327

    Biological/Vaccine

    Intravenous infusion

Treatment groups

594 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Part 1 - BNT324 + BNT327 combination therapyExperimental treatment 2 interventions
Group B: Part 2 - Cohort 1: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327Experimental treatment 2 interventions
Group C: Part 2 - Cohort 2: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327Experimental treatment 2 interventions
Group D: Part 2 - Cohort 3: RP2D of BNT324 + BNT327Experimental treatment 2 interventions
Group E: Part 2 - Cohort 4: RP2D of BNT324 + BNT327Experimental treatment 2 interventions
Group F: Part 2 - Cohort 5: RP2D of BNT324 + BNT327Experimental treatment 2 interventions
Group G: Part 2 - Cohort 6: RP2D of BNT324 + BNT327Experimental treatment 2 interventions
Group H: Part 2 - Cohort 7: RP2D of BNT324 + BNT327Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part 1 - Occurrence of dose limiting toxicities (DLTs) by dose level

Time frame
During the DLT evaluation period, i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days]
2

Part 1 - Occurrence of Treatment-emergent adverse events (TEAEs), serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by dose level

Time frame
From the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first
3

Part 1 - Occurrence of dose interruption, reduction, and treatment discontinuations due to TEAEs by dose level

Time frame
From the time of the first dose of IMP to 90 days after the last dose of IMP or until new anticancer therapy is started, whichever occurs first
4

Part 2 cohorts 1 and 2 - Occurrence of TEAEs, serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by cohort and treatment arm

Time frame
From the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first

Secondary outcomes

1

Part 1 - ORR by dose level

ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST version 1.1 based on the investigator's assessment).

Time frame
From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months
2

Part 1 - Disease control rate (DCR) by dose level

DCR, defined as the proportion of participants with confirmed CR, PR, or stable disease (SD) as best overall response (per RECIST version 1.1 based on the investigator's assessment).

Time frame
From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months
3

Part 2 all cohorts - (PFS) by cohort and treatment arm

PFS defined as the time from first dose of IMP to the first objective tumor progression (PD) or death from any cause, whichever occurs first, per RECIST version 1.1 based on the investigator's assessment.

Time frame
From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months
4

Part 2 all cohorts - Duration of response (DOR) by cohort and treatment arm

DOR, defined as the time from first objective response (CR or PR) to first occurrence of objective tumor progression (PD) or death from any cause, whichever occurs first (per RECIST version 1.1 based on the investigator's assessment).

Time frame
From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BioNTech SE

Lead sponsor

DualityBio Inc.

Collaborator

Source ClinicalTrials.gov
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