A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorDaiichi Sankyo
About this trial
This study will assess the safety and tolerability of valemetostat in combination with darolutamide in participants with Metastatic Castration Resistant Prostate Cancer (mCRPC).
Eligibility criteria
Qualifiers
Adult males ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is >18 years old).
Histologically confirmed adenocarcinoma of the prostate. Cases exhibiting neuroendocrine differentiation are eligible for enrollment, except those with a diagnosis of pure small cell carcinoma, which is excluded.
Evidence of disease progression as per the PCWG3 modified RECIST v1.1 criteria.
Evidence of metastatic disease as confirmed by radiographic imaging (CT, MRI, or bone scan).
Disqualifiers
Prior treatment with any epigenetic agents including but not limited to EZH1, EZH2, EZH1/2, or PRC2 inhibitors.
Has a super scan as seen in the baseline bone scan. A super scan is defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan, such that the presence of additional metastases in the future could not be evaluated.
Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
Uncontrolled or significant cardiovascular disease,
Trial design
Treatments tested in this trial
- Valemetostat
- Darolutamide
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Daiichi Sankyo
Lead sponsor
Bayer
Collaborator
Source ClinicalTrials.gov