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New treatment option for Metastatic Castration-resistant Prostate Cancer
Official title A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
ClinicalTrials.gov ID: NCT07244341
What this study is testing
What is Valemetostat?
Valemetostat is an investigational medicine, being studied as a potential treatment for metastatic castration-resistant prostate cancer.
Also referred to as DS-3201.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will assess the safety and tolerability of valemetostat in combination with darolutamide in participants with Metastatic Castration Resistant Prostate Cancer (mCRPC).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Key The clinical site will screen for the full per protocol.
- 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...
- Histologically confirmed adenocarcinoma of the prostate. Cases exhibiting neuroendocrine differentiation are eligible for enrollment, except those...
- 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).
You likely can't join if
- The clinical site will screen for the full exclusion criteria per protocol.
- 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...
- Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring...
- Uncontrolled or significant cardiovascular disease,
- Prior malignancy, active within the previous 3 years except for locally curable cancers that have been apparently cured or successfully resected...
See the full eligibility criteria
- Key The clinical site will screen for the full per protocol.
- 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).
- Ongoing androgen deprivation at time of enrollment.
- For participants currently being treated with luteinizing hormone-releasing hormone agonists or antagonists, therapy must have been initiated at least 4 weeks prior to enrollment and treatment must be continued...
- Baseline PSA expression level of ≥2 ng/mL, according to a documented testing result.
- Prior therapy with an Androgen Receptor Pathway Inhibitors (ARPI).
- ECOG PS of 0 or 1 assessed no more than 28 days prior to enrollment.
- Is willing and able to provide adequate fresh or archival tumor samples with sufficient quantity and tissue quality. A mandatory newly obtained pretreatment biopsy is required, if not clinically contraindicated and at...
- A male participant capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate each trial intervention. The length of...
- Must not freeze or donate sperm starting at screening and throughout the Treatment Period, and for at least 3 months after the final trial intervention administration. Note: Preservation of sperm should be considered...
- Adhere to either of the following contraception methods:
- True abstinence from penile-vaginal intercourse, when this is in line with the preferred and usual lifestyle of the participant, OR
- Uses a penile/external condom when having penile-vaginal intercourse with an NPOCBP, PLUS partner use of an additional contraceptive method, as a condom may break or leak Contraceptive use should be consistent with...
- The clinical site will screen for the full exclusion criteria per protocol.
- 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...
- 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,
- Prior malignancy, active within the previous 3 years except for locally curable cancers that have been apparently cured or successfully resected, such as basal or squamous cell carcinoma, superficial bladder cancer...
- Has active or uncontrolled HBV infection.
- Has active or uncontrolled HCV infection.
- Has active or uncontrolled HIV infection.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Boston, Massachusetts, United States
- Newton, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Lake Success, New York, United States
- Myrtle Beach, South Carolina, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Milwaukee, Wisconsin, United States
- Guangzhou, China
- Shanghai, China
- Wenzhou, China
- Dublin, Ireland
- Kashiwa-shi, Japan
- Kobe, Japan
- Kōtoku, Japan
- Sakura-shi, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Boston, Massachusetts, United States; Newton, Massachusetts, United States; Grand Rapids, Michigan, United States; Lake Success, New York, United States; Myrtle Beach, South Carolina, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.