Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07103018

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

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

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
144 (estimated)
Sponsor
K36 Therapeutics, Inc. · Industry
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

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

Timeline

Start date
2025-11-21
Primary completion
2027-09-01
Completion
2028-09-01
First posted
2025-08-05
Last updated
2026-03-23

Locations

13 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07103018. Inclusion in this directory is not an endorsement.