STRIKE-001: KTX-2001 plus darolutamide for mCRPC - Clinical Trial
What is the Purpose of this Study?
This study has five parts: screening, treatment, end of treatment, safety check, and long-term follow-up.
- Part A: People will try different amounts of a new medicine called KTX-2001 to find the safest dose.
- Part B: People will take the best dose of KTX-2001 along with another medicine called darolutamide.
KTX-2001 is taken on an empty stomach. Darolutamide is taken with food twice a day. You will get medicine to take at home and write down when you take it in a diary.
You will have regular check-ups, scans, heart tests, and maybe a biopsy. After treatment, doctors will check on you for safety and follow up every few months until your cancer gets worse or you start a new treatment.
Metastatic Castration-Resistant Prostate Cancer
Who Can Participate in the Study?
People in this study must:
- Be men who are 18 years old or older.
- Have a serious kind of prostate cancer called metastatic castration-resistant prostate cancer (mCRPC), which means the cancer has spread and does not respond to hormone treatment.
- Have cancer that has spread to bones or soft tissues, shown by special scans like bone scans, CT scans, or MRIs.
- Be willing to have a small sample taken from the cancer area before and during treatment, if it is safe.
- Have already tried a kind of medicine called ARPI (like abiraterone or enzalutamide) and the cancer kept growing.
- Be on hormone treatment for at least 6 months or have had surgery to remove both testicles, with very low testosterone levels.
- Have had chemotherapy before for prostate cancer.
- Have signs that the cancer is getting worse.
- If joining a special part of the study, be able to eat a high-fat meal and not eat for 12 hours before.
What is Involved?
This study is trying to find the safest and best amount of two new medicines called KTX-2001 and darolutamide. These medicines are being tested to see if they help people with a serious kind of prostate cancer called metastatic castration-resistant prostate cancer (mCRPC). The medicines may be given alone or together to see which works better.
Study Details
