Keystone Urology Specialists | Lancaster, PA
Status and phase
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About
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.
Full description
ORIC-944 is a potent, highly selective, allosteric, orally bioavailable, small molecule inhibitor of PRC2 via binding the embryonic ectoderm development (EED) subunit.
This is a first-in-human, open-label, multicenter, dose escalation study of ORIC-944 as a single agent (Part I) or in combination with an Androgen Receptor Pathway Inhibitor (ARPI) (Part II) to establish the safety and preliminary antitumor activity of ORIC-944 as a single agent and in combination with ARPIs in patients with metastatic prostate cancer. Part III of the protocol (dose optimization) will explore two potential dose levels of ORIC-944 selected from Part II in combination with ARPIs to select the final RP2D for each combination across two separate patient populations.
Enrollment
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Volunteers
Inclusion criteria
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
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
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
250 participants in 3 patient groups
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Central trial contact
ORIC Clinical
Data sourced from clinicaltrials.gov
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