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.
Who Can Participate?
Eligibility
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.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Phase 1, Dose-Escalation Study of KTX-2001 (an NSD2 Inhibitor) Alone and in Combination with Darolutamide for Metastatic Castration-Resistant Prostate Cancer, K36-MCRPC-001
Principal Investigator
Andrew
Armstrong
Protocol Number
PRO00118873
NCT ID
NCT07103018
Phase
I
Enrollment Status
Pending Open to Enrollment