ClinicaliQ Trial Snapshot
- Study of ORIC-944 in Patients With Metastatic Prostate Cancer — Recruiting • Phase I • Oncology • NCT05413421.
- What is being tested: ORIC-944, a novel therapeutic agent, is being evaluated both as monotherapy and in combination with androgen receptor pathway inhibitors (ARPIs) to assess safety and antitumor efficacy in metastatic prostate cancer.
- Patient eligibility overview: The trial enrolls patients with metastatic prostate cancer; specific eligibility criteria typically include confirmed diagnosis, adequate organ function, and defined prior treatment history, though precise criteria vary by study arm.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The purpose of this study is to establish the safety and preliminary antitumor activity of ORIC-944 as a single agent and in combinations with ARPIs in patients with metastatic prostate cancer.
Eligibility Snapshot
- : * 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: received only one 1 prior line of apalutamide, darolutamide, or enzalutamide in any setting: * Evidence of progressive disease by PCWG3 criteria for study entry * rising PSA, defined as a minimum of 2 rising values obtained a minimum of one week apart…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.