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

Part of paid clinical trials in San Francisco, California.

Sponsor
K36 Therapeutics, Inc.
Study ID
NCT07103018
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KTX-2001 — DRUG
    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 Details

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.

Key Dates

Start date
Nov 21, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
144 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Dose Escalation Monotherapy
    KTX-2001 orally
  • Experimental: Part B: Dose Escalation Combination
    KTX-2001 orally Darolutamide (NUBEQA®) orally as 600 mg BID, total daily dose at 1200 mg

Primary Outcome Measure

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

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94158
GU Recruitment
[email protected]
Ivan de Kouchkovsky, MD (PRINCIPAL_INVESTIGATOR)
Sylvester Comprehensive Cancer CenterMiamiFlorida33136
Nailet Real Bestard
[email protected]
305-243-8173
Marijo Bilusic, MD, PhD (PRINCIPAL_INVESTIGATOR)
Hematology Oncology Associates of the Treasure CoastPort Saint LucieFlorida34952
Joe Dima
[email protected]
772-408-5162
Seth Rosen, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Clinical Trials Referral Office
855-776-0015
Elisabeth Heath, MD (PRINCIPAL_INVESTIGATOR)
START New York Long Island, LLCNew Hyde ParkNew York11042
Camilita Goberdhan
[email protected]
347-476-1959
Geraldine O'Sullivan Coyne, MD, PhD (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical CenterNew YorkNew York10032
Nurse Navigators
[email protected]
212-342-5162
Alexander Wei, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10032
Wassim Abida, MD
[email protected]
646-422-4633
Wassim Abida, MD, PhD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
David Wise, MD (PRINCIPAL_INVESTIGATOR)
Duke Cancer CenterDurhamNorth Carolina27710
Hannah McManus, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Fuat Bicer, MD, PhD (PRINCIPAL_INVESTIGATOR)
Carolina Urologic Research Center, the START Center for Cancer ResearchMyrtle BeachSouth Carolina29572
Jennifer Sutton
[email protected]
843-449-1010
Neal Shore, MD, FACS (PRINCIPAL_INVESTIGATOR)
USA Clinical TrialsSan AntonioTexas78229
Manuel Hernandez
[email protected]
210-617-4116
Jose De La Cerda, III, MD (PRINCIPAL_INVESTIGATOR)
University of WisconsinMadisonWisconsin53705
UWCCC Clinical Trials Navigation Team
[email protected]
608-262-0439
Anthony Serritella, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
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By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California San Francisco· San Francisco, CASylvester Comprehensive Cancer Center· Miami, FLHematology Oncology Associates of the Treasure Coast· Port Saint Lucie, FLMayo Clinic· Rochester, MNSTART New York Long Island, LLC· New Hyde Park, NYColumbia University Irving Medical Center· New York, NY

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