Study of ORIC-944 in Patients With Metastatic Prostate Cancer
An Open-Label, Phase 1/1b Study of ORIC-944 as a Single Agent or in Combination With an Androgen Receptor Pathway Inhibitor in Patients With Metastatic Prostate Cancer
Sponsor: ORIC Pharmaceuticals
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Recommended Phase 2 Dose (RP2D)
Time frame: 12 months
Maximum plasma concentration (Cmax)
Time frame: 28 Days
Time to maximum observed concentration (Tmax)
Time frame: 28 Days
Area under the curve (AUC)
Time frame: 28 Days
Secondary Endpoints
Clinical benefit rate (CBR)
Objective response rate (ORR)
Duration of response (DOR)
Eligibility Criteria
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 therapies are allowed, but must have progressed after at least one line of next generation ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide) and must not have received more than 2 chemotherapy regimens in the mCRPC setting Part II (ARPI combination dose escalation): Must have received only 1 prior line of ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide) in any setting; may have also received up to 1 prior line of chemotherapy in the mCSPC setting Part III (ARPI combination dose optimization): In addition to up to 1 prior line of chemotherapy in the mCSPC setting: * Cohorts A and B: received only one 1 prior line of abiraterone in any setting * Cohorts C and D: receive…
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