An Open-Label, Phase 1/1b Study of ORIC-944 in Patients with Metastatic Prostate Cancer

MC #UC23-02

Prostate Cancer
Molecular Target(s)
Not Required
Drug Classification(s)
Small Molecule

Mechanism of Action

Potent, highly selective, allosteric, orally bioavailable, small molecule inhibitor of
PRC2 via binding the embryonic ectoderm development (EED) subunit


The primary purposes of Part I are to select a dose of ORIC-944 (also referred to as the
“study drug”) that is safe and well tolerated and measure the amount of study drug present
in your blood at various time points. The secondary purpose will be to evaluate whether
ORIC-944 provides any clinical benefit by measuring the size of tumor lesions.
The primary purposes of Part II are to select a dose of ORIC-944 that is safe and well
tolerated in combination with apalutamide, darolutamide, or enzalutamide and to
measure the amount to ORIC-944 in your blood when co-administered with those drugs.
Finally, the sponsor will also evaluate how ORIC-944 affects certain blood components
(eg, hemoglobin) as well as certain other proteins in blood which are specific to your
disease (ie, biomarkers). This may help them understand how ORIC-944 works and how
it may help improve cancer treatment.



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