KTX-2001 for Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)
This study is testing a new drug called KTX-2001 for men with metastatic castration-resistant prostate cancer (mCRPC). This is prostate cancer that has spread to other parts of the body and is no longer responding to standard hormone therapy. Researchers want to see if KTX-2001 is safe and how it works, both by itself and when combined with another approved prostate cancer drug called darolutamide (NUBEQA®). The main goal is to find the highest dose of KTX-2001 that can be given safely. You might be able to join if you are a man aged 18 or older with mCRPC and meet other health requirements. The study is currently recruiting about 144 participants.
- Study design
- This is an open-label Phase 1 study, meaning both you and the study team will know which treatment you are receiving. It plans to enroll 144 participants.
- What's involved
- Participants will receive increasing doses of KTX-2001, either alone or in combination with darolutamide (NUBEQA®).
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary safety measure is assessed at 21 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)
At a glance
Conditions
Where it's being run
13 sites across 9 statesStudy leadership
- Jason Redman, MD · STUDY_DIRECTOR · K36 Therapeutics
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Percentage of patients with dose-limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD)21 days