USO 24310
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 (ORIC-944-01)
Disease Types: Genitourinary Cancer Research
Eligibility Requirements:
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:
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 with the latest result being at least 2.0 ng/mL (or 1.0 ng/mL if PSA rise is the only indication of progression), or
confirmation of 2 new bone lesions on last systemic therapy, or
soft tissue progression per RECIST 1.1
Measurable and/or evaluable disease by RECIST 1.1
Agreement and ability to undergo on-study punch skin biopsies and core tumor biopsies
ECOG performance status of 0 or 1
Adequate organ function
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