Actively Recruiting
Phase 1 Dose-Escalation Study of KTX-2001 Alone and With Darolutamide for Metastatic Castration-Resistant Prostate Cancer
Led by K36 Therapeutics, Inc. · Updated on 2026-03-23
144
Participants Needed
13
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating KTX-2001, alone and in combination with darolutamide, in men with metastatic castration-resistant prostate cancer (mCRPC). This first-in-human Phase 1 clinical trial aims to study the safety, how the drug behaves in the body, and its initial effectiveness in treating mCRPC. The goal is to find safe dose levels and understand how KTX-2001 works with darolutamide, an oral androgen receptor pathway inhibitor. Participants will receive escalating doses of KTX-2001 either by itself or combined with darolutamide taken orally at a dose of 600 mg twice a day (total 1200 mg daily). The study has two parts: Part A tests KTX-2001 alone, and Part B tests the combination with darolutamide. Doses will increase to assess tolerance and safety, with treatment given continuously during the study periods. During the trial, participants will have regular assessments including biopsies of metastatic sites when possible, blood tests to monitor safety and drug levels, and scans to confirm metastatic disease. Researchers will track dose-limiting toxicities over 21 days to determine maximum tolerated doses and monitor adverse events for up to three years. The study team will also evaluate pharmacokinetics and recommend doses for future studies, with total participation lasting up to about three years.
CONDITIONS
Brief 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
- Male participants with metastatic castration-resistant prostate cancer as defined by PCWG3 criteria
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Metastatic disease confirmed by bone scan, CT, or MRI (PSMA PET alone is insufficient)
- Willingness to undergo baseline and on-treatment biopsy of metastatic site if safe and feasible
- Previous progression on or after androgen receptor pathway inhibitor therapy (eg, abiraterone, enzalutamide, darolutamide, apalutamide)
- Adequate kidney function (creatinine clearance >50 mL/min)
- Adequate liver function with specified bilirubin, AST, and ALT limits
- Adequate blood counts with no recent transfusions within 2 weeks
You will not qualify if you...
- Symptomatic or uncontrolled brain metastases unless treated and stable for at least 28 days
- Leptomeningeal disease
- Untreated or unstable symptomatic or impending spinal cord compression
- Life-threatening illness, active uncontrolled infection, or organ dysfunction compromising safety or study integrity
- Unresolved drug-related toxicity from prior cancer therapy (except alopecia and grade 2 neuropathy)
- Active uncontrolled infections including HBV, HCV, or HIV without controlled viral load
- Significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or liver disease affecting participation
- QT interval corrected >470 msec
- Unstable cardiovascular conditions including symptomatic ischemia, certain arrhythmias, heart failure class III or higher, recent heart attack
- Uncontrolled hypertension (>150/90 mmHg despite treatment)
- Use of strong CYP3A inducers or inhibitors within 10 days or 5 half-lives prior to first dose
- Recent anticancer therapies within 2-4 weeks depending on therapy type
- Use of other investigational agents within 4 weeks prior to study drug
- Major surgery within 28 days prior to study drug without recovery
- Initiation of hormonal agents with anti-prostate cancer activity during study participation (stable 5-alpha reductase inhibitors allowed with 6 months continuous use)
- Use of herbal or alternative therapies with hormonal activity or PSA effects within 4 weeks prior to study drug or planned during study
- For combination part: use of drugs that are combined P-glycoprotein and CYP3A4 inducers within 10 days or 5 half-lives prior to darolutamide first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until dose escalation is complete or discontinuation
Participants receive escalating doses of KTX-2001 alone or in combination with darolutamide to evaluate safety, pharmacokinetics, and preliminary efficacy.
Multiple visits for dosing and monitoring during treatment cycles
Duration - Up to 1095 days
Participants are monitored for safety, adverse events, and long-term outcomes after treatment completion.
Periodic visits for safety assessments
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
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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