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Clinical Trials in Turkey / NCT06892548
Recruiting Phase 1/2

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

NCT06892548 · tracked via the Priya Life Science Turkey tracker
Sponsor
BioNTech SE
Phase
Phase 1/2
Started
2025-05-02
Last updated
2026-08-26

Condition(s) studied

Advanced Lung Cancer

Investigational drug(s) / intervention(s)

BNT324 →BNT327 →

BNT324: Intravenous infusion

BNT327: Intravenous infusion

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Part 1 - Occurrence of dose limiting toxicities (DLTs) by dose level — During the DLT evaluation period, i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days]
  • Part 1 - Occurrence of Treatment-emergent adverse events (TEAEs), serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by dose level — 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
  • Part 1 - Occurrence of dose interruption, reduction, and treatment discontinuations due to TEAEs by dose level — 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
  • Part 2 cohorts 1 and 2 - Occurrence of TEAEs, serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by cohort and treatment arm — 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
  • Part 2 cohorts 1 and 2 - Occurrence of dose interruption, reduction, and treatment discontinuation due to TEAEs by cohort and treatment arm — 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
  • Part 2 cohorts 1 and 2 - Objective response rate (ORR) by cohort and treatment arm — From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months
    ORR defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) is observed as best overall response (per response evaluation criteria in solid tumors \[RECIST\] version 1.1 based on the investigator's assessment).
  • Part 2 cohorts 3-7 - ORR by cohort — From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months
    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).

Trial sites (91)

FacilityCityRegionStatus
Mayo Clinic Arizona Phoenix Arizona Recruiting
Precision NextGen Oncology and Research Center Beverly Hills California Recruiting
Cedars Sinai Medical Center Los Angeles California Recruiting
UCLA - David Geffen School of Medicine Santa Monica California Recruiting
University of Colorado Cancer Center Aurora Colorado Recruiting
Mayo Clinic in Florida Jacksonville Florida Recruiting
University of Iowa Hospitals & Clinics PARENT Iowa City Iowa Recruiting
Mayo Clinic-Rochester Rochester Minnesota Recruiting
Regional Cancer Care Associates Belleville New Jersey Recruiting
John Theurer Cancer Center at Hackensack UMC Hackensack New Jersey Recruiting
Memorial Sloan Kettering Cancer Center (MSKCC) New York New York Recruiting
Icahn School of Medicine at Mount Sinai PRIME New York New York Recruiting
Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center Cleveland Ohio Recruiting
Texas Oncology - DFW Dallas Texas Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
Texas Oncology - Northeast Tyler Texas Recruiting
Virginia Cancer Specialists Fairfax Virginia Recruiting
Chris O'Brien Lifehouse Camperdown New South Wales Recruiting
Flinders Medical Centre Bedford Park South Australia Recruiting
Bendigo Hospital Bendigo Victoria Recruiting
Barwon Health Geelong Victoria Recruiting
Sunshine Hospital Saint Albans Victoria Recruiting
St John of God Subiaco Hospital Subiaco Western Australia Recruiting
Anhui Provincial Cancer Hospital Hefei Anhui Recruiting
Beijing Cancer Hospital Beijing Beijing Municipality Recruiting
Beijing GoBroad Hospital Beijing Beijing Municipality Recruiting
Fujian Medical University Union Hospital Fuzhou Fujian Recruiting
Fujian Cancer Hospital Fuzhou Fujian Recruiting
Guangxi Medical University Cancer Hospital Nanning Guangxi Zhuang Recruiting
The First Affiliated Hospital of Xinxiang Medical University Weihui Henan Recruiting
Henan Provincial Cancer Hospital Zhengzhou Henan Recruiting
Jingzhou First People's Hospital Jingzhou Hubei Recruiting
Xiangyang Central Hospital Xiangyang Hubei Recruiting
Yichang Central People's Hospital Yichang Hubei Recruiting
Hunan Province People's Hospital Changsha Hunan Recruiting
Nanjing Chest Hospital Nanjing Jiangsu Recruiting
The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi Recruiting
Jiangxi Cancer Hospital Nanchang Jiangxi Recruiting
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi Recruiting
Jilin Cancer Hospital Changchun Jilin Recruiting

+ 51 more sites — see the full list on the official registry below.

More BioNTech SE trials in Turkey

A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC) Recruiting
Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy Active, not recruiting
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer Recruiting
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy Active, not recruiting
A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06892548 on ClinicalTrials.gov ↗ ← All trials in Turkey