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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
BioNTech SE
Study ID
NCT06892548
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BNT324 — BIOLOGICAL
    Intravenous infusion
  • BNT327 — BIOLOGICAL
    Intravenous infusion

Study 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).

Key Dates

Start date
May 2, 2025
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Jun 30, 2031

Study Design

Enrollment
594 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
    In SCLC, 1L

Primary Outcome Measure

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] ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona13400-
Precision NextGen Oncology and Research CenterBeverly HillsCalifornia90212-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
UCLA - David Geffen School of MedicineSanta MonicaCalifornia90404-
University of Colorado Cancer CenterAuroraColorado80045-
Mayo Clinic in FloridaJacksonvilleFlorida32224-
University of Iowa Hospitals & Clinics PARENTIowa CityIowa52242-
Mayo Clinic-RochesterRochesterMinnesota55905-
John Theurer Cancer Center at Hackensack UMCHackensackNew Jersey07601-
Icahn School of Medicine at Mount Sinai PRIMENew YorkNew York10029-
Memorial Sloan Kettering Cancer Center (MSKCC)New YorkNew York10021-
Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer CenterClevelandOhio44195-
Texas Oncology - DFWDallasTexas75246-
MD Anderson Cancer CenterHoustonTexas77030-
Texas Oncology - NortheastTylerTexas75702-
Virginia Cancer SpecialistsFairfaxVirginia22031-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Arizona· Phoenix, AZPrecision NextGen Oncology and Research Center· Beverly Hills, CACedars Sinai Medical Center· Los Angeles, CAUCLA - David Geffen School of Medicine· Santa Monica, CAUniversity of Colorado Cancer Center· Aurora, COMayo Clinic in Florida· Jacksonville, FL

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