RecruitingPhase 1Phase 2NCT06892548

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

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

Sponsor

BioNTech SE

Enrollment

594 participants

Start Date

May 2, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Lung Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug combination — BNT324 and BNT327 — in people with advanced or metastatic lung cancer (both non-small cell and small cell lung cancer types) that cannot be removed by surgery. The trial includes both early dose-finding stages and later stages comparing the new drugs to standard treatment. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic lung cancer confirmed by biopsy or cell testing - Depending on the stage of the study, you may be eligible with either non-small cell or small cell lung cancer, and at various lines of treatment - If your cancer has a specific gene mutation (AGA-positive), you must have already tried targeted therapy **You may NOT be eligible if...** - You have not tried required prior treatments for your lung cancer subtype - You have serious organ problems that would make the treatment unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBNT324

Intravenous infusion

BIOLOGICALBNT327

Intravenous infusion

Locations(58)

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

Henan Provincial Cancer Hospital

Zhengzhou, Henan, China

Jingzhou First People's Hospital

Jingzhou, Hubei, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

Yichang Central People's Hospital

Yichang, Hubei, China

Nanjing Chest Hospital

Nanjing, Jiangsu, 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

Jinan Central Hospital

Jinan, Shandong, China

Shandong Cancer Hospital

Jinan, Shandong, China

Shanghai GoBroad Cancer Hospital

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, 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

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

St George's Hospitals NHS Foundation Trust

London, United Kingdom

University College London Hospital

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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