Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05413421 | Study of ORIC-944 in Patients With Metastatic Prostate Cancer | PHASE1 | RECRUITING | 250 | — | — | Jun 1, 2022 | Sep 1, 2026 | Aug 11, 2025 | 27 | United States, Australia +2 |
RP2D as determined by interval 3+3 dose escalation design
PK of ORIC-944 single agent and in combination with an ARPI
PK of ORIC-944 single agent and in combination with an ARPI
PK of ORIC-944 single agent and in combination with an ARPI
PK of ORIC-944 single agent and in combination with an ARPI
| Arm | Type | Description |
|---|---|---|
| Single Agent Dose Escalation | EXPERIMENTAL | ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles |
| Combination Dose Escalation | EXPERIMENTAL | ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles in combinations with abiraterone, apalutamide, darolutamide, or enzalutamide |
| Combination Dose Optimization | EXPERIMENTAL | Cohort A and C: ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles in combination with apalutamide Cohort B and D: ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles in combination with darolutamide Combinations with abiraterone or enzalutamide may be conducted in the future |
| Name | Type | Description |
|---|---|---|
| ORIC-944 | DRUG | Oral, once daily, continuous |
| Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets | DRUG | Oral, 1000 mg once daily, continuous |
| Apalutamide (Erleada™) 60 mg or 240 mg tablets | DRUG | Oral, 240 mg once daily, continuous |
| Darolutamide (Nubeqa®) 300 mg tablets | DRUG | Oral, 600 mg twice daily, continuous |
| Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets | DRUG | Oral, 160 mg once daily, continuous |
Inclusion Criteria: * Patients with metastatic prostate cancer * Must have undergone bilateral orchiectomy or be willing to continue GnRH analogue or antagonist to maintain castrate levels of testosterone * Prior therapies: Part I (single agent ORIC-944 dose escalation): Any number of prior therap...