Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT07103018
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.
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.
Study:
NCT07103018
Study Brief:
Protocol Section:
NCT07103018