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NCT07103018 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Metastatic Castration-Resistant Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer (mCRPC), sponsored by K36 Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
144
Enrollment target
13
Study locations

NCT07103018: Recruiting Phase 1 study of Metastatic Castration-Resistant Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer (mCRPC), sponsored by K36 Therapeutics.

NCT07103018 is a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer (mCRPC) that is actively recruiting participants, run by K36 Therapeutics. The registered enrollment target is 144 participants, below the 196-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (27% lower). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07103018, a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer (mCRPC), is actively recruiting participants, sponsored by K36 Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
144 participants
Enrollment target
13
Study locations

Study 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 Studied

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

Interventions

  • DRUG KTX-2001
  • DRUG KTX-2001 + Darolutamide (NUBEQA®)

Study Locations (13)

New York

  • START New York Long Island, LLC - New Hyde Park
  • NYU Langone Health - New York
  • Columbia University Irving Medical Center - New York
  • Memorial Sloan Kettering Cancer Center - New York

Florida

  • Sylvester Comprehensive Cancer Center - Miami
  • Hematology Oncology Associates of the Treasure Coast - Port Saint Lucie

California

  • University of California San Francisco - San Francisco

Minnesota

  • Mayo Clinic - Rochester

North Carolina

  • Duke Cancer Center - Durham

Ohio

  • The Ohio State University Comprehensive Cancer Center - Columbus

South Carolina

  • Carolina Urologic Research Center, the START Center for Cancer Research - Myrtle Beach

Texas

  • USA Clinical Trials - San Antonio

Trial Details

FieldValue
Enrollment Target 144 participants
Start Date 2025-11-21
Est. Completion 2028-09
Phase Phase 1
K36 Therapeutics

2 total trials

What NCT07103018 shows while recruiting

NCT07103018 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 196-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (27% lower).

The record links to 5 conditions, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which KTX-2001 is the first listed.

NCT07103018 lists 13 locations in 9 states (New York, Florida, California).

Frequently Asked Questions

What is clinical trial NCT07103018 about?

NCT07103018 is a clinical study titled "A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)". 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 i...

What is the current status of trial NCT07103018?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 144 participants. The study started on 2025-11-21. Estimated completion is 2028-09.

What conditions does trial NCT07103018 study?

This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer (mCRPC), mCRPC (Metastatic Castration-resistant Prostate Cancer), mCRPC, Metastatic Castration-Resistant Prostate Cancer Patients.

What interventions are being tested in trial NCT07103018?

The interventions under investigation include: KTX-2001 (DRUG), KTX-2001 + Darolutamide (NUBEQA®) (DRUG).

Who is sponsoring clinical trial NCT07103018?

This trial is sponsored by K36 Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07103018 being conducted?

This trial has 13 study locations across California, Florida, Minnesota, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Castration-Resistant Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07103018's enrollment target sits among peer trials

144 22nd of 69 higher than 48 of 69 other Metastatic Castration-Resistant Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Castration-Resistant Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07103018

Source: ClinicalTrials.gov NCT07103018, the US trial registry maintained by the National Library of Medicine. NCT07103018 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.