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.

NCT07103018

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

Recruiting
PHASE1Ages 18+InterventionalTreatment
K36 Therapeutics, Inc.
~144 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:KTX-2001KTX-2001 + Darolutamide (NUBEQA®)

At a glance

Recruiting sites
12 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of patients with dose-limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD)
Measured over 21 days
Metastatic Castration-resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer Patients
Metastatic Castration-resistant Prostate Cancer, mCRPC
mCRPC
mCRPC (Metastatic Castration-resistant Prostate Cancer)
13 sites across 9 states
New York4
Florida2
California1
Minnesota1
North Carolina1
Ohio1
South Carolina1
Texas1
  • Jason Redman, MD · STUDY_DIRECTOR · K36 Therapeutics

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  • Percentage of patients with dose-limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD)21 days