Study on Investigating a New Combination Therapy with BNT324 and BNT327 for Advanced Lung Cancer
Sponsor: BioNTech SE
ClinicalTrials ID:NCT06892548
This clinical trial is exploring a new treatment that combines two investigational drugs, BNT324 and BNT327, to see if they are safe and effective in treating advanced lung cancer, including both small cell and non-small cell types.
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Program Overview
The study aims to test a new combination of two drugs, BNT324 and BNT327, in patients with advanced or returning lung cancer. BNT324 is a type of drug that targets cancer cells, while BNT327 is designed to help the immune system fight cancer. The study will look at how safe these drugs are when used together and whether they can help control lung cancer that has spread or come back after treatment.
Description
This study is divided into two parts. In the first part, researchers will test different doses of the drug combination to find the safest and most effective dose for patients with advanced lung cancer. This includes both small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). In the second part, the study will focus on how well the best dose works in different groups of patients, including those who have not had treatment before and those whose cancer has returned after previous treatments.
Participants will go through a screening process to ensure they meet the study requirements. They will then receive the combination treatment and be monitored for safety and effectiveness. The study includes a treatment period, a follow-up period to check for any side effects, and a long-term follow-up to see how well patients do over time.
The study will help determine if this new combination therapy can be a beneficial treatment option for people with advanced lung cancer.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have advanced or metastatic lung cancer that cannot be removed by surgery.
- Cancer must be confirmed by lab tests.
- Must have measurable cancer that can be tracked during the study.
- Must be in good overall health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must have a life expectancy of at least 12 weeks.
Exclusion Criteria
- Have previously received treatment targeting B7-H3.
- Have received certain types of cancer drugs called ADCs with topoisomerase inhibitors, unless in specific study groups.
- Are eligible for treatments that could completely or nearly completely remove the cancer, such as surgery or targeted radiation.
- Have had severe blood-related side effects from previous cancer treatments.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Virginia Cancer Specialists | 22031 | Fairfax | Virginia |
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