Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as DS-3201
Valemetostat · 1 trial · 1 indication
A DLT is defined as any Treatment Emergent Adverse Event (TEAE) not attributable to disease or disease-related processes, environmental factors, unrelated trauma, etc, that occurs during the DLT evaluation period (Day 1 to Day 28) and is Grade ≥3.
TEAEs are defined as those Adverse Events (AEs) with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 30 days after the last dose date of trial intervention).
| Arm | Type | Description |
|---|---|---|
| Part 1 (Dose Escalation) | EXPERIMENTAL | Participants will receive valemetostat at escalating doses in combination with darolutamide. |
| Part 2 (Dose Expansion) | EXPERIMENTAL | Participants will receive valemetostat at 2 or more dose levels in combination with darolutamide. |
| Name | Type | Description |
|---|---|---|
| Valemetostat | DRUG | Dose Escalation Part: Valemetostat will be administered at escalating doses. Dose Expansion Part: Valemetostat will be administered at 2 or more dose levels. |
| Darolutamide | DRUG | Dose Escalation Part: Darolutamide will be administered at a standard dose. Dose Expansion Part: Darolutamide will be administered at a standard dose. |
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 c...