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

March 19, 2026 updated by: K36 Therapeutics, Inc.

Phase 1, Dose-Escalation Study of KTX2001 (an NSD2 Inhibitor) Alone and in Combination With Darolutamide for Metastatic Castration-Resistant Prostate Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study K36-MCRPC-001 (also know as K36-STRIKE-001) is a multicenter, open-label Phase 1 study for participants with metastatic castration-resistant prostate cancer (mCRPC) to investigate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of KTX-2001 monotherapy and KTX-2001 in combination with darolutamide (NUBEQA®), and to establish a recommended Phase 2 dose(s) of KTX-2001 for future study.

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California San Francisco
        • Principal Investigator:
          • Ivan de Kouchkovsky, MD
        • Contact:
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • Sylvester Comprehensive Cancer Center
        • Principal Investigator:
          • Marijo Bilusic, MD, PhD
        • Contact:
      • Port Saint Lucie, Florida, United States, 34952
        • Recruiting
        • Hematology Oncology Associates of the Treasure Coast
        • Contact:
        • Principal Investigator:
          • Seth Rosen, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Elisabeth Heath, MD
        • Contact:
          • Clinical Trials Referral Office
          • Phone Number: 855-776-0015
    • New York
      • New Hyde Park, New York, United States, 11042
        • Recruiting
        • START New York Long Island, LLC
        • Contact:
        • Principal Investigator:
          • Geraldine O'Sullivan Coyne, MD, PhD
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Principal Investigator:
          • David Wise, MD
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Contact:
        • Principal Investigator:
          • Alexander Wei, MD
      • New York, New York, United States, 10032
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Wassim Abida, MD, PhD
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Center
        • Principal Investigator:
          • Hannah McManus, MD
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Not yet recruiting
        • The Ohio State University Comprehensive Cancer Center
        • Principal Investigator:
          • Fuat Bicer, MD, PhD
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Carolina Urologic Research Center, the START Center for Cancer Research
        • Contact:
        • Principal Investigator:
          • Neal Shore, MD, FACS
    • Texas
      • San Antonio, Texas, United States, 78229
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • University of Wisconsin
        • Principal Investigator:
          • Anthony Serritella, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years.
  2. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
  3. Male participants with mCRPC as defined by PCWG3 criteria.
  4. Metastatic disease documented using bone scan for bone metastases (PCWG3 criteria) or by computed tomography (CT) or magnetic resonance imaging (MRI) for soft-tissue metastases. Evidence of metastasis on prostate-specific membrane antigen positron emission tomography alone will not be sufficient for confirmation of metastatic disease.
  5. Willingness to undergo a baseline and on-treatment biopsy of a metastatic site if safe and feasible. If tissue from a biopsy of a metastatic site (including bone) obtained within the previous 6 months (prior to treatment start) is available, this tissue may be used, and the baseline biopsy may be omitted.
  6. Participants should have progressed on or after receiving an ARPI (eg, abiraterone, enzalutamide, darolutamide, or apalutamide).
  7. Adequate renal function (creatinine clearance >50 mL/min by serum creatinine).
  8. Adequate hepatic function (total bilirubin ≤1.5× ULN, total bilirubin <3× ULN for participants with documented Gilbert's syndrome, AST and ALT ≤2.5× ULN). In case of liver metastases, AST and ALT <5× ULN is allowed.
  9. Adequate hematological function (neutrophils >1 × 109/L, platelet count >100 × 109/L, hemoglobin >9 g/dL) with no prior transfusions within 2 weeks.

Exclusion Criteria:

  1. Presence of symptomatic or uncontrolled brain metastases unless adequately treated, not requiring steroids and stable for the last 28 calendar days before signing the ICF. Participants with leptomeningeal disease are excluded without exception.
  2. Symptomatic or impending cord compression that has not been treated or stabilized.
  3. Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction (such as coagulopathy or encephalopathy), or other reasons which, in the investigator's opinion, could compromise the participant's safety or interfere with or compromise the integrity of the study outcomes.
  4. Presence of a drug-related toxicity from prior cancer therapy that has not resolved to Grade ≤1 (with the exception of alopecia and Grade 2 neuropathy) according to NCI-CTCAE Version 5.0.
  5. Active, uncontrolled, bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness. In equivocal cases, participants with a negative viral load may be eligible. Eligibility criteria for HIV-positive participants currently on highly active antiretroviral therapy should be evaluated and discussed with the medical monitor and will be based on current and past CD4 and T cell counts, history (if any) of AIDS-defining conditions (eg, opportunistic infections), and status of HIV treatment. Participants with previously treated HBV and HCV with negative viral load are eligible.

  6. A significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that, in the opinion of the investigator, would adversely affect participation in this study.

    1. QT interval corrected by Fridericia's formula >470 msec at screening.
    2. Unstable cardiovascular function defined as:
    3. Symptomatic ischemia, or
    4. Uncontrolled clinically significant conduction abnormalities (ie, ventricular tachycardia on antiarrhythmic agents are excluded; first-degree atrioventricular block or asymptomatic left anterior fascicular block/right bundle branch block are not excluded), or
    5. Congestive heart failure New York Heart Association Class ≥3, or
    6. Myocardial infarction within 3 months of the screening visit.
    7. Hypertension that cannot be controlled (persistent >150/90 mmHg despite optimal medical therapy).
  7. Current use or anticipated need for food or drugs that are known strong CYP3A inducers or inhibitors, including their administration within 10 days or 5 half-lives of the CYP3A inhibitor, whichever is longer prior to first dose of study drug.
  8. Treatment with anticancer therapies including radiotherapy or AR-targeted therapy/androgen biosynthesis inhibitor) within 2 weeks prior to initial study drug dose or within 4 weeks for systemic chemotherapy, radioligand therapy, or other systemic anticancer therapies.
  9. Treatment with another investigational agent in the 4 weeks prior to the initial dose of study drug.
  10. Major surgical procedures ≤28 days prior to the initial dose of study drug. Participants must have recovered from any of the effects of any major surgery. No waiting period is required following central venous access placement, biopsy collection, or minor surgeries as long as the investigator assesses the impact on study participation.
  11. Initiation of hormonal agents with antitumor activity against prostate cancer including 5alpha reductase inhibitors, androgens (eg, testosterone), cytoproterone acetate, etc during study participation (from the time of consent to off-study); however, stable use of 5-alpha reductase inhibitors is permitted, if continuous use for ≥6 months.
  12. Use of herbal products or alternative therapies that may decrease PSA levels or that may have hormonal anti-prostate cancer activity (eg, saw palmetto, PC-SPES, PC-HOPE, St. John's wort, selenium supplements, grape seed extract, etc) within 4 weeks of study drug initiation or plans to initiate treatment with these products/alternative therapies at any point during the study.

For Part B only (KTX-2001 + darolutamide): Current use or anticipated need for drugs that are known as combined P-glycoprotein (P-gp) and strong or moderate CYP3A4 inducers including their administration within 10 days or 5 half-lives of the combined Pgp/CYP3A4 inducer, whichever is longer prior to first dose of darolutamide.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part B: Dose Escalation Combination
KTX-2001 orally Darolutamide (NUBEQA®) orally as 600 mg BID, total daily dose at 1200 mg
Drug: KTX-2001 + Darolutamide (NUBEQA®)
Participants will receive escalating doses of KTX-2001, in combination with the oral androgen receptor (AR) pathway inhibitor (ARPI), darolutamide (NUBEQA®)
Experimental: Part A: Dose Escalation Monotherapy
KTX-2001 orally
Drug: KTX-2001
Participants will receive escalating doses of KTX-2001 monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with dose-limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD)
Time Frame: 21 days
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall safety profile including adverse events
Time Frame: up to 1095 days
up to 1095 days
Recommended Phase 2 dose (RP2D) of KTX-2001
Time Frame: up to 1095 days
up to 1095 days
Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)
Time Frame: up to 48 hours
Characterize PK parameters of KTX-2001 when administered as a single agent or in combination with darolutamide
up to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

K36 Therapeutics, Inc.

Investigators

  • Study Director: Jason Redman, MD, K36 Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

July 21, 2025

First Submitted That Met QC Criteria

July 28, 2025

First Posted (Actual)

August 5, 2025

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K36-MCRPC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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