Actively Recruiting
A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)
Led by K36 Therapeutics, Inc. · Updated on 2026-03-23
144
Participants Needed
13
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Study K36-MCRPC-001 is the first in human clinical trial testing KTX-2001 alone and with darolutamide in men with metastatic castration-resistant prostate cancer. The study aims to assess whether the drug is safe, increasing doses alone and in combination with darolutamide, whether it is effective in treating metastatic castration-resistant prostate cancer, and measuring how the drug(s) behaves in the body.
CONDITIONS
Official Title
A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Male participants with metastatic castration-resistant prostate cancer (mCRPC) as defined by PCWG3 criteria
- Metastatic disease confirmed by bone scan, CT, or MRI (positron emission tomography alone is not sufficient)
- Willingness to undergo baseline and on-treatment biopsy of a metastatic site if safe and feasible, or availability of recent biopsy tissue
- Progression after receiving an androgen receptor pathway inhibitor (e.g., abiraterone, enzalutamide, darolutamide, or apalutamide)
- Adequate kidney function (creatinine clearance >50 mL/min)
- Adequate liver function (total bilirubin ≤1.5× ULN, or ≤3× ULN for Gilbert's syndrome; AST and ALT ≤2.5× ULN or ≤5× ULN if liver metastases present)
- Adequate blood function (neutrophils >1×10^9/L, platelets >100×10^9/L, hemoglobin >9 g/dL) with no transfusions within 2 weeks
You will not qualify if you...
- Symptomatic or uncontrolled brain metastases unless treated, stable, and not requiring steroids for at least 28 days; leptomeningeal disease excluded
- Untreated or unstable symptomatic or impending spinal cord compression
- Life-threatening illnesses, uncontrolled infections, or organ dysfunction affecting safety or study integrity
- Unresolved drug-related toxicity from prior cancer therapy above Grade 1 (except alopecia and Grade 2 neuropathy)
- Active, uncontrolled infections including hepatitis B, hepatitis C, HIV/AIDS-related illness; treated and controlled cases may be eligible
- Significant history of renal, neurologic, psychiatric, pulmonary, endocrine, metabolic, immunologic, cardiovascular, or liver disease affecting participation
- QT interval corrected by Fridericia's formula >470 msec
- Unstable heart conditions including symptomatic ischemia, certain conduction abnormalities, severe heart failure, recent heart attack, or uncontrolled hypertension
- Current or anticipated use of strong CYP3A inducers or inhibitors within 10 days or 5 half-lives prior to study drug
- Recent anticancer therapies within 2 weeks for most treatments or 4 weeks for chemotherapy or radioligand therapy
- Use of another investigational agent within 4 weeks prior to study drug
- Major surgery within 28 days prior to study drug without recovery
- Initiation of hormonal agents with antitumor activity during study except stable use of 5-alpha reductase inhibitors for at least 6 months
- Use of herbal or alternative therapies that may affect PSA or have anti-prostate cancer activity within 4 weeks or planned during study
- For combination part: use or need for drugs that strongly induce combined P-glycoprotein and CYP3A4 within 10 days or 5 half-lives prior to darolutamide initiation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
2
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
3
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States, 34952
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
5
START New York Long Island, LLC
New Hyde Park, New York, United States, 11042
Actively Recruiting
6
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
7
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10032
Actively Recruiting
9
Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
10
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Not Yet Recruiting
11
Carolina Urologic Research Center, the START Center for Cancer Research
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
12
USA Clinical Trials
San Antonio, Texas, United States, 78229
Actively Recruiting
13
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
K
K36 Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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