An Open-Label, Phase 1/1b Study of ORIC-944 in Patients with Metastatic Prostate Cancer
An Open-Label, Phase 1/1b Study of ORIC-944 in Patients with Metastatic Prostate Cancer
Mechanism of Action
Potent, highly selective, allosteric, orally bioavailable, small molecule inhibitor ofPRC2 via binding the embryonic ectoderm development (EED) subunit
Purpose
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.
- Patients with metastatic prostate cancer, including those with neuroendocrine prostate cancer (NEPC) and/or small cell features
- Must have undergone bilateral orchiectomy or be willing to continue GnRH analogue or antagonist to maintain castrate levels of testosterone throughout the duration of the study
- Any number of prior therapies are allowed, but must have progressed on or after at least one line of next generation androgen receptor antagonist (abiraterone, enzalutamide, apalutamide, darolutamide) and must not have received more than 2 chemotherapy regimens in the mCRPC setting
Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured per investigator judgement and/or not requiring active treatment with systemic therapy
Must have undergone bilateral orchiectomy or be willing to continue GnRH analogue or antagonist to maintain castrate levels of testosterone throughout the duration of the study
Any number of prior therapies are allowed, but must have progressed on or after at least one line of next generation androgen receptor antagonist (abiraterone, enzalutamide, apalutamide, darolutamide) and must not have received more than 2 chemotherapy regimens in the mCRPC setting
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