Ongoing Clinical Trials for HER2 Protein Overexpression
There is currently 1 ongoing clinical trial for patients with HER2 protein overexpression. This trial is investigating a new treatment approach combining BDC-1001, an experimental immunotherapy agent, with nivolumab, an established immune system medication, for advanced HER2-positive solid tumors. The trial is being conducted in France and aims to determine the safety, tolerability, and effectiveness of this treatment combination.
Clinical trial locations
Study of BDC-1001 and Nivolumab for Patients with Advanced HER2-Positive Solid Tumors
This clinical trial is testing new treatment options for patients with advanced solid tumors that have the HER2 protein on their surface. This protein can cause cancer to grow more quickly. The study examines an experimental medication called BDC-1001, both alone and in combination with nivolumab, a drug that helps the immune system fight cancer.
Main inclusion criteria:
- Patients must be 18 years or older
- Must have advanced solid tumors expressing HER2 protein (either low or high levels) for which no approved treatments are available or tolerable
- Must have recovered from any major surgery for at least 4 weeks
- Must have a performance status of 0 or 1, meaning they are either fully active or have some symptoms but can carry out light work
- Must have a life expectancy of more than 12 weeks
- Heart function must be adequate, with a left ventricular ejection fraction of 50% or higher
- The tumor must be measurable using standard criteria
- Must be able to provide tumor tissue samples for research purposes
- Women of childbearing potential must use highly effective contraception during the study and for 7 months after treatment ends
- Men must use condoms along with another highly effective contraceptive method during the study and for 7 months after treatment ends
Main exclusion criteria:
- Patients without advanced HER2-expressing solid tumors
- Patients who are pregnant or breastfeeding
- Patients participating in another clinical trial at the same time
- Patients who have not recovered from recent major surgery
- Patients with a history of severe allergic reactions to similar treatments
- Patients with active infections requiring treatment
- Patients with another type of cancer that might interfere with study results
- Patients unable to understand or follow study instructions
Focus and goal of the trial:
The study is conducted in multiple phases. In the first phase, patients receive BDC-1001 alone through an intravenous infusion to assess its safety and tolerability. The purpose is to determine the most appropriate dosage for further study.
The second phase involves combining BDC-1001 with nivolumab, also given through infusion. This phase evaluates whether the combination is safe and helps identify the recommended dose for future research.
In the third phase, the study expands to include more patients to evaluate how well the treatments work in reducing tumor size or slowing tumor growth. The final phase involves ongoing monitoring through regular blood samples and imaging tests to assess treatment response and identify any side effects.
Investigational drugs:
The trial uses two medications. BDC-1001 is an experimental immunotherapy agent that targets the HER2 protein on cancer cells, potentially helping the immune system attack these cells more effectively. Nivolumab (also known by its code names BMS936558 and ABP 206) is a medication that works by helping the immune system recognize and fight cancer cells. The study examines whether using these medications together can provide better results than using BDC-1001 alone.
Summary
Currently, only one clinical trial is available for patients with HER2 protein overexpression, and it is being conducted in France. This trial represents an innovative approach by combining a new investigational agent (BDC-1001) with an established immunotherapy medication (nivolumab). The study follows a structured approach, starting with single-agent testing before moving to combination therapy, which allows researchers to carefully evaluate safety before examining effectiveness. Patients interested in participating should meet specific health criteria, including adequate heart function and sufficient recovery from previous treatments. The trial requires a commitment to contraception and regular monitoring throughout the treatment period.
