What is the Purpose of this Study?
The purpose of this study is to assess whether the investigational drugs BNT324 and BNT327 can help control advanced or metastatic lung cancer. The study aims to determine the most suitable combination dose of BNT324 and BNT327 (i.e., the dose that has the most benefit while minimizing side effects or other risks). Researchers also want to identify the side effects of BNT324 and BNT327. Part 1 of the study will focus on researching various dose combinations. Once the appropriate combination dose is identified for future research, Part 2 of the study will further evaluate the safety and effectiveness of the drugs. Additionally, the study will assess how BNT324 and BNT327 move into, through, and out of the body (pharmacokinetics), as well as how the study drugs and cancer affect patients’ quality of life. BNT324 and BNT327 will be given as an infusion directly into the vein. BNT324 is an "antibody-drug conjugate," which means it consists of 2 parts that work together: an antibody and a drug. When BNT324 binds to a specific protein on the tumor cell, it releases a drug that can cause the death of the tumor cell. BNT327 is a "bispecific antibody," which means it is designed to bind to 2 different targets (proteins on cancer cells or their surrounding area). By binding to these proteins, BNT327 aims to reduce factors that allow cancer cells to grow and spread.
Eligibility
- * 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
Where can I participate?
- CS Cancer at Beverly Hills : Maria Tarallo
- CS Cancer at Cedars-Sinai Medical Center : Maria Tarallo
More about this Clinical Trial
What is the full name of this clinical trial?
BNT324-01: 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