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NCT06892548

PHASE1/PHASE2

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

Sponsor: BioNTech SE

View on ClinicalTrials.gov

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).

Official title: A Phase Ib/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Recommended Combination Dose of BNT324 With BNT327 in Participants With Advanced Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

594

Start Date

2025-05-02

Completion Date

2031-06

Last Updated

2026-03-19

Healthy Volunteers

Conditions

Advanced Lung Cancer

Interventions

BIOLOGICAL

BNT324

Intravenous infusion

BIOLOGICAL

BNT327

Intravenous infusion

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.

Locations (52)

Mayo Clinic Arizona

Phoenix, Arizona, United States

Precision NextGen Oncology and Research Center

Beverly Hills, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

UCLA - David Geffen School of Medicine

Santa Monica, California, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

University of Iowa Hospitals & Clinics PARENT

Iowa City, Iowa, United States

Mayo Clinic-Rochester

Rochester, Minnesota, United States

John Theurer Cancer Center at Hackensack UMC

Hackensack, New Jersey, United States

Memorial Sloan Kettering Cancer Center (MSKCC)

New York, New York, United States

Icahn School of Medicine at Mount Sinai PRIME

New York, New York, United States

Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Texas Oncology - DFW

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Texas Oncology - Northeast

Tyler, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Bendigo Hospital

Bendigo, Victoria, Australia

Barwon Health

Geelong, Victoria, Australia

Sunshine Hospital

Saint Albans, Victoria, Australia

St John of God Subiaco Hospital

Subiaco, Western Australia, Australia

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing GoBroad Hospital

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi Zhuang, China

The First Affiliated Hospital of Xinxiang Medical University

Weihui, Henan, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

Linyi Cancer Hospital

Shandong, Linyi, China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Shandong Cancer Hospital

Jinan, Shandong, China

Shanghai GoBroad Cancer Hospital

Shanghai, Shanghai Municipality, China

First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Jingzhou First People's Hospital

Jingzhou, China

Henan Provincial Cancer Hospital

Zhengzhou, China

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Adana City Hospital

Adana, Turkey (Türkiye)

Hacettepe University Medical Faculty

Ankara, Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

Ankara, Turkey (Türkiye)

Ankara City Hospital

Ankara, Turkey (Türkiye)

Yeditepe University Medical School Hospital

Istanbul, Turkey (Türkiye)

Koc University Hospital

Istanbul, Turkey (Türkiye)

Sakarya Training and Research Hospital

Sakarya, Turkey (Türkiye)

Bristol Haematology and Oncology Centre

Bristol, United Kingdom

St. James's University Hospital

Leeds, United Kingdom

University College London Hospital

London, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (52)