Study of ORIC-944 in Patients With Metastatic Prostate Cancer

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to establish recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) and preliminary antitumor activity of ORIC-944 in patients with metastatic prostate cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ORIC Pharmaceuticals

Criteria

Inclusion Criteria:

• 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

• Any number of prior therapies are allowed, but must have progressed 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

• 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

Exclusion Criteria:

• History or presence of CNS metastases, unless previously treated and stable

• History of class III or IV congestive heart failure or severe non-ischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months

• Known, symptomatic human immunodeficiency virus (HIV) infection

• Active symptomatic Hepatitis B or C infection; patients with well controlled disease are eligible

• Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, short gut syndrome, etc) or other malabsorption syndromes that would reasonably impact drug absorption per investigator judgement

• Any other condition or circumstance (eg, clinical, psychological, familial, sociological, inability to swallow oral study drug) that, in the opinion of the investigator, may interfere with protocol compliance or contraindicates participation in the study