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

PHASE1RecruitingINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

October 8, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2028

Conditions
Metastatic Castration-resistant Prostate CancerMetastatic Castration-Resistant Prostate Cancer PatientsMetastatic Castration-resistant Prostate Cancer, mCRPCmCRPCmCRPC (Metastatic Castration-resistant Prostate Cancer)
Interventions
DRUG

KTX-2001

Participants will receive escalating doses of KTX-2001 monotherapy

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®)

Trial Locations (2)

10032

NOT_YET_RECRUITING

Memorial Sloan Kettering Cancer Center, New York

78229

RECRUITING

USA Clinical Trials, San Antonio

Sponsors
All Listed Sponsors
lead

K36 Therapeutics, Inc.

INDUSTRY