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Metastatic Castration-resistant Prostate CancerPhase 1STRIKE-001NCT07103018

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

A Phase 1 study testing KTX-2001 and KTX-2001 + Darolutamide (NUBEQA®) in people with Metastatic Castration-resistant Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer Patients, run by K36 Therapeutics, Inc. at 13 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
KTX-2001 and KTX-2001 + Darolutamide (NUBEQA®)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
13 sitesUnited States
Study dates
21 Nov 2025to Sep 2028
Phase
Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years.
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
  • Male participants with mCRPC as defined by PCWG3 criteria.
  • 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.
  • 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.
  • Participants should have progressed on or after receiving an ARPI (eg, abiraterone, enzalutamide, darolutamide, or apalutamide).
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  • Adequate renal function (creatinine clearance >50 mL/min by serum creatinine).
  • 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.
  • Adequate hematological function (neutrophils >1 × 109/L, platelet count >100 × 109/L, hemoglobin >9 g/dL) with no prior transfusions within 2 weeks.

Who cannot join

  • 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.
  • Symptomatic or impending cord compression that has not been treated or stabilized.
  • 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.
  • 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.
  • 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.
  • 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.
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  • QT interval corrected by Fridericia's formula >470 msec at screening.
  • Unstable cardiovascular function defined as:
  • Symptomatic ischemia, or
  • 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
  • Congestive heart failure New York Heart Association Class ≥3, or
  • Myocardial infarction within 3 months of the screening visit.
  • Hypertension that cannot be controlled (persistent >150/90 mmHg despite optimal medical therapy).
  • 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.
  • 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.
  • Treatment with another investigational agent in the 4 weeks prior to the initial dose of study drug.
  • 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.
  • 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.
  • 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.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

K36 Clinical Operations contact

6173475787

strike-001@k36tx.com

13 sites in 1 country

United States13 sites, 13 recruiting

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Fuat Bicer, MD, PhD

    Recruiting

  • Duke Cancer Center

    Durham, North Carolina, 27710

    Hannah McManus, MD

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53705

    UWCCC Clinical Trials Navigation Team, 608-262-0439, clinicaltrials@cancer.wisc.edu

    Anthony Serritella, MD

    Recruiting

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

    Nailet Real Bestard, 305-243-8173, nxr518@med.miami.edu

    Marijo Bilusic, MD, PhD

    Recruiting

  • Carolina Urologic Research Center, the START Center for Cancer Research

    Myrtle Beach, South Carolina, 29572

    Jennifer Sutton, 843-449-1010 ext. 5316, jennifer.sutton@startresearch.com

    Neal Shore, MD, FACS

    Recruiting

  • START New York Long Island, LLC

    New Hyde Park, New York, 11042

    Camilita Goberdhan, 347-476-1959, camilita.goberdhan@startresearch.com

    Geraldine O'Sullivan Coyne, MD, PhD

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    David Wise, MD

    Recruiting

  • Columbia University Irving Medical Center

    New York, New York, 10032

    Nurse Navigators, 212-342-5162, cancerclinicaltrials@cumc.columbia.edu

    Alexander Wei, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10032

    Wassim Abida, MD, 646-422-4633, abidam@mskcc.org

    Wassim Abida, MD, PhD

    Recruiting

  • Hematology Oncology Associates of the Treasure Coast

    Port Saint Lucie, Florida, 34952

    Joe Dima, 772-408-5162, jdima@hemoncfl.com

    Seth Rosen, MD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Clinical Trials Referral Office, 855-776-0015

    Elisabeth Heath, MD

    Recruiting

  • USA Clinical Trials

    San Antonio, Texas, 78229

    Manuel Hernandez, 210-617-4116, manuel.hernandez@usa-clinicaltrials.com

    Jose De La Cerda, III, MD

    Recruiting

  • University of California San Francisco

    San Francisco, California, 94158

    GU Recruitment, GUtrials@ucsf.edu

    Ivan de Kouchkovsky, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
KTX-2001, KTX-2001 + Darolutamide (NUBEQA®)
Keywords
mCRPC, Metastatic Castration-Resistant Prostate Cancer, castration-resistant prostate cancer, NSD2 inhibitor, efficacy, safety, pharmacokinetics, pharmacodynamics, Darolutamide, NUBEQA, Metastatic Disease, Neoplasms, prostatic Diseases, Prostatic Neoplasms, Urogenital Neoplasms, Neoplasms by Site, Urogenital Diseases, Male Urogenital Diseases, Epigenetics
Medical subject headings
Neoplasm Metastasis, Neoplasms, Prostatic Diseases, Prostatic Neoplasms, Urogenital Neoplasms, Neoplasms by Site, Urogenital Diseases, Male Urogenital Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KTX-2001Drug

    Participants will receive escalating doses of KTX-2001 monotherapy

  • KTX-2001 + Darolutamide (NUBEQA®)Drug

    Participants will receive escalating doses of KTX-2001, in combination with the oral androgen receptor (AR) pathway inhibitor (ARPI), darolutamide (NUBEQA®)

Study groups in NCT07103018
Study groupRoleWhat they receive
Part A: Dose Escalation MonotherapyExperimentalKTX-2001 orally
Receives: Drug: KTX-2001
Part B: Dose Escalation CombinationExperimentalKTX-2001 orally Darolutamide (NUBEQA®) orally as 600 mg BID, total daily dose at 1200 mg
Receives: Drug: KTX-2001 + Darolutamide (NUBEQA®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients with dose-limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD)

    Measured: 21 days

Secondary outcomes (3)

  1. Overall safety profile including adverse events

    Measured: up to 1095 days

  2. Recommended Phase 2 dose (RP2D) of KTX-2001

    Measured: up to 1095 days

  3. Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)

    Characterize PK parameters of KTX-2001 when administered as a single agent or in combination with darolutamide

    Measured: up to 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2025
  2. Study start21 Nov 2025
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07103018
Sponsor's protocol ID
K36-MCRPC-001
Acronym
STRIKE-001
Status last verified
Mar 2026
First submitted
21 Jul 2025
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

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