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.
Age ≥18 years.
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
Male participants with mCRPC as defined by PCWG3 criteria.
Metastatic disease documented using bone scan for bone metastases (PCWG3 criteria) or by computed tomography (CT) or magnetic resonance imaging (MRI) for soft-tissue metastases. Evidence of metastasis on prostate-specific membrane antigen positron emission tomography alone will not be sufficient for confirmation of metastatic disease.
Presence of symptomatic or uncontrolled brain metastases unless adequately treated, not requiring steroids and stable for the last 28 calendar days before signing the ICF. Participants with leptomeningeal disease are excluded without exception.
Symptomatic or impending cord compression that has not been treated or stabilized.
Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction (such as coagulopathy or encephalopathy), or other reasons which, in the investigator's opinion, could compromise the participant's safety or interfere with or compromise the integrity of the study outcomes.
Presence of a drug-related toxicity from prior cancer therapy that has not resolved to Grade ≤1 (with the exception of alopecia and Grade 2 neuropathy) according to NCI-CTCAE Version 5.0.
Sequential
KTX-2001
DrugParticipants will receive escalating doses of KTX-2001 monotherapy
KTX-2001 + Darolutamide (NUBEQA®)
DrugParticipants will receive escalating doses of KTX-2001, in combination with the oral androgen receptor (AR) pathway inhibitor (ARPI), darolutamide (NUBEQA®)
Percentage of patients with dose-limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD)
Overall safety profile including adverse events
Recommended Phase 2 dose (RP2D) of KTX-2001
Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)
Characterize PK parameters of KTX-2001 when administered as a single agent or in combination with darolutamide
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