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

Trial status:Recruiting
Trial ID:
BNT324-01
NCT ID:
NCT06892548
EudraCT ID:
N/A
EU Trial (CTIS) Number:
2024-520238-31-00
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Recruiting

Trial Details

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).

Medical Condition
  • Lung Cancer
    • Trial Drug
  • BNT324
    • See more
  • BNT327
    • Phase
    Phase 1/Phase 2
    Type
    Interventional
    Estimated Enrolment
    594
    Estimated Trial Date
    May 2025 - Aug 2027

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No
    Inclusion and Exclusion Criteria
    Inclusion criteria

      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.

    Trial Locations

    Location
    Status
    Location
    Precision NextGen Oncology and Research Center
    Beverly Hills, California, United States, 90212
    Status
    Recruiting
    Location
    John Theurer Cancer Center at Hackensack UMC
    Hackensack, New Jersey, United States, 07601
    Status
    Recruiting
    Location
    Virginia Cancer Specialists
    Fairfax, Virginia, United States, 22031
    Status
    Recruiting
    Location
    Guangxi Medical University Cancer Hospital
    Nanning, Guangxi Zhuang, China, 530021
    Status
    Recruiting
    Location
    Xiangyang Central Hospital
    Xiangyang, Hubei, China, 441021
    Status
    Recruiting
    Location
    Hacettepe University Medical Faculty
    Ankara, Unmapped, 06100
    Status
    Recruiting
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