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

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Lung Cancer

In brief

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 facts

Study ID

NCT06892548

Run by

BioNTech SE

People needed

594

Starts

2025-05-02

Expected to finish

2032-05-01

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Precision NextGen Oncology and Research Center — Beverly Hills, California, United States (enrolling)
• Cedars Sinai Medical Center — Los Angeles, California, United States (enrolling)
• UCLA - David Geffen School of Medicine — Santa Monica, California, United States (enrolling)
• University of Colorado Cancer Center — Aurora, Colorado, United States (enrolling)
• Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)
• University of Iowa Hospitals & Clinics PARENT — Iowa City, Iowa, United States (enrolling)
• Mayo Clinic-Rochester — Rochester, Minnesota, United States (enrolling)
• John Theurer Cancer Center at Hackensack UMC — Hackensack, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Cancer Center (MSKCC) — New York, New York, United States (enrolling)
• Icahn School of Medicine at Mount Sinai PRIME — New York, New York, United States (enrolling)
• Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center — Cleveland, Ohio, United States (enrolling)
• Texas Oncology - DFW — Dallas, Texas, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Texas Oncology - Northeast — Tyler, Texas, United States (enrolling)
• Virginia Cancer Specialists — Fairfax, Virginia, United States (enrolling)
• Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia (enrolling)
• Flinders Medical Centre — Bedford Park, South Australia, Australia (enrolling)
• Bendigo Hospital — Bendigo, Victoria, Australia (enrolling)
• Barwon Health — Geelong, Victoria, Australia (enrolling)
• Sunshine Hospital — Saint Albans, Victoria, Australia (enrolling)
• St John of God Subiaco Hospital — Subiaco, Western Australia, Australia (enrolling)
• Anhui Provincial Cancer Hospital — Hefei, Anhui, China (enrolling)
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)
• Beijing GoBroad Hospital — Beijing, Beijing Municipality, China (enrolling)
• Mayo Clinic Arizona — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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