A Phase 1 Clinical Study to Investigate the Safety and Pharmacokinetics of MK-5684 in Japanese Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC)

Koh Yasuhiro0 sites8 target enrollmentNovember 4, 2023

Overview

No summary available.

Registry

who.int

Start Date

November 4, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

Male

Sponsor

Koh Yasuhiro

•Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology and Have received, or been intolerant to, all treatment known to confer clinical benefit.
•\- Have current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by CT/MRI.
•\- Have ongoing androgen deprivation with serum testosterone \<50 ng/dL (\<1\.7 nmol/L).
•\- Participants receiving bone anti\-resorptive therapy must have been on stable doses for \>\=4 weeks prior to the start of study intervention.
•\- Have progressed on or after treatment with at least 1 line of next generation hormonal agents (NHAs) in metastatic hormone\-sensitive prostate cancer (mHSPC) or in CRPC for a minimum of 12 weeks (e.g. abiraterone, enzalutamide, darolutamide, apalutamide), and with at least 1 line of taxane\-based chemotherapy in mHSPC or in CRPC, or ineligibility for chemotherapy.
•\- Have prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening, as determined by the investigator through one of the following:
•\- PSA progression
•\- Radiographic disease progression in soft tissue based on RECIST 1\.1, with or without PSA progression
•\- Radiographic disease progression in bone per Prostate Cancer Working Group (PCWG) 3
•\- Have a performance status of 0 or 1 on the ECOG Performance Scale

•\- Has a history of pituitary dysfunction.
•\- Has brain metastases.
•\- History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
•\- Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
•\- Has an active infection or other medical condition that would make corticosteroid contraindicated.
•\- Has serious persistent infection within 2 weeks prior to the start of the study intervention.
•\- Participants on an unstable dose of thyroid hormone therapy within 6 months prior to the start of the study intervention.
•\- Has poorly controlled diabetes mellitus.
•\- Hypotension or uncontrolled hypertension.
•\- Has clinically significant abnormal serum potassium or sodium level.