A Phase 1, Multicenter Trial Evaluating the Safety, Tolerability, and Efficacy of Valemetostat (DS-3201) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
Daiichi Sankyo
Summary
This study will assess the safety and tolerability of valemetostat in combination with darolutamide in participants with Metastatic Castration Resistant Prostate Cancer (mCRPC).
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Key Inclusion Criteria: The clinical site will screen for the full inclusion criteria per protocol. 1. 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). 2. 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. 3. Evidence of disease progression as per the PCWG3 modified RECIST v1.1 criteria. 4. Evidence of metas…
Interventions
- DrugValemetostat
Dose Escalation Part: Valemetostat will be administered at escalating doses. Dose Expansion Part: Valemetostat will be administered at 2 or more dose levels.
- DrugDarolutamide
Dose Escalation Part: Darolutamide will be administered at a standard dose. Dose Expansion Part: Darolutamide will be administered at a standard dose.
Locations (6)
- Carolina Urologic Research CenterMyrtle Beach, South Carolina
- NEXT OncologySan Antonio, Texas
- Virginia Cancer Specialists (NEXT Virginia)Fairfax, Virginia
- Kobe City Med Cen Gen Hosp.Kobe
- Cancer Institute Hospital of JFCRKōtoku
- Toho University Sakura Medical CenterSakura-shi