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

NCT07103018 | Recruiting Phase 1 FDA Drug

• 1 other identifier: K36-MCRPC-001
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 13

Brief 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 metastatic castration-resistant prostate cancer, and measuring how the drug(s) behaves in the body.

Conditions

Metastatic Castration-Resistant Prostate Cancer Patients; Metastatic Castration-resistant Prostate Cancer, mCRPC; mCRPC; mCRPC (Metastatic Castration-resistant Prostate Cancer); Metastatic Castration-resistant Prostate Cancer

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

Outcome Measures

Primary Outcomes (1)

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

  21 days

Secondary Outcomes (3)

• Overall safety profile including adverse events

  up to 1095 days

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

  up to 1095 days

• Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)

  up to 48 hours

Study Arms (2)

Part A: Dose Escalation Monotherapy

EXPERIMENTAL

KTX-2001 orally

Drug: KTX-2001

Part B: Dose Escalation Combination

EXPERIMENTAL

KTX-2001 orally Darolutamide (NUBEQA®) orally as 600 mg BID, total daily dose at 1200 mg

Drug: KTX-2001 + Darolutamide (NUBEQA®)

Interventions

KTX-2001 DRUG

Participants will receive escalating doses of KTX-2001 monotherapy

Part A: Dose Escalation 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®)

Part B: Dose Escalation Combination

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• K36 Therapeutics, Inc.: lead

Study Sites (13)

University of California San Francisco

San Francisco, California, 94158, United States

RECRUITING

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

RECRUITING

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, 34952, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

START New York Long Island, LLC

New Hyde Park, New York, 11042, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10032, United States

RECRUITING

Duke Cancer Center

Durham, North Carolina, 27710, United States

RECRUITING

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

Carolina Urologic Research Center, the START Center for Cancer Research

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

USA Clinical Trials

San Antonio, Texas, 78229, United States

RECRUITING

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms; Prostatic Diseases; Prostatic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urogenital Diseases; Male Urogenital Diseases

Interventions

darolutamide

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Diseases, Male; Genital Diseases; Genital Neoplasms, Male; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Jason Redman, MD

  K36 Therapeutics

  STUDY DIRECTOR

Central Study Contacts

K36 Clinical Operations

CONTACT

9139806941; strike-001@k36tx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 5, 2025
• Study Start: November 21, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (13)