> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-oric-944-in-patients-with-metastatic-prostate-de63fe34-55cf-4992-89ce-e34d781f1227 > Record changed: 2026-10-13 # Study of ORIC-944 in Patients With Metastatic Prostate Cancer NCT05413421 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) Participants 275 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) Lead sponsor ORIC Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) Start date 2022-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) Number of sites 27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) **Short title** Study of ORIC-944 in Patients With Metastatic Prostate Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) ## Dates **Completion date** 2028-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) **First posted** 2022-06-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) **Registry last updated** 2026-07-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) **Primary completion date** 2027-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) **Start date** 2022-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) ## Size and sites **Participants** 275 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) **Planned participants** 275 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) **Number of sites** 27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) **Lead sponsor** ORIC Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) ## Identifiers **Registry ID** NCT05413421 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) **ClinicalTrials.gov ID** NCT05413421 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) ## Outcomes ### Primary outcomes 1. Recommended Phase 2 Dose (RP2D) Timeframe: 12 months RP2D as determined by interval 3+3 dose escalation design 2. Maximum plasma concentration (Cmax) Timeframe: 28 Days PK of ORIC-944 single agent and in combination with an ARPI 3. Time to maximum observed concentration (Tmax) Timeframe: 28 Days PK of ORIC-944 single agent and in combination with an ARPI 4. Area under the curve (AUC) Timeframe: 28 Days PK of ORIC-944 single agent and in combination with an ARPI 5. Apparent plasma terminal elimination half-life (t1/2) Timeframe: 28 Days PK of ORIC-944 single agent and in combination with an ARPI ### Secondary outcomes 1. Clinical benefit rate (CBR) Timeframe: 36 months Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 2. Objective response rate (ORR) Timeframe: 36 months Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 3. Duration of response (DOR) Timeframe: 36 months Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 4. Progression-free survival (PFS) Timeframe: 36 months Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 5. On-treatment PSA levels and change from baseline Timeframe: 36 months Prostate cancer working group 3 criteria (PCWG3) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) ## Eligibility **Sex** Male **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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: - 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 - 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) ## Sites - Rocky Mountain Cancer CenterColorado Springs, United StatesRecruiting - South Florida Oncology and HematologyPlantation, United StatesRecruiting - Illinois Cancer SpecialistsArlington Heights, United StatesRecruiting - Comprehensive Urologic CareLake Barrington, United StatesRecruiting - First UrologyJeffersonville, United StatesRecruiting - Marlene & Stewart Greenebaum Comprehensive Cancer Center, University of MarylandBaltimore, United StatesRecruiting - Maryland Oncology HematologySilver Spring, United StatesRecruiting - KarmanosDetroit, United StatesRecruiting - Minnesota Oncology HematologyMinneapolis, United StatesRecruiting - Memorial Sloane Kettering Cancer CenterNew York, United StatesRecruiting - Levine Cancer InstituteCharlotte, United StatesRecruiting - MidLantic UrologyBala-Cynwyd, United StatesNot yet recruiting - Keystone Urology SpecialistsLancaster, United StatesRecruiting - Amarillo Urology ResearchAmarillo, United StatesRecruiting - Urology Clinics of North TexasDallas, United StatesRecruiting - Huntsman Cancer Institute, University of UtahSalt Lake City, United StatesRecruiting - Virginia Oncology AssociatesFairfax, United StatesRecruiting - Virginia Cancer SpecialistsNorfolk, United StatesNot yet recruiting - University of Washington, Fred Hutchinson Cancer CenterSeattle, United StatesRecruiting - University of Wisconsin Carbone Cancer CenterMadison, United StatesNot yet recruiting - Sydney Adventist HealthWahroonga, AustraliaRecruiting - Bendigo HealthBendigo, AustraliaRecruiting - Peninsula HealthFrankston, AustraliaNot yet recruiting - NEXT OncologyBarcelona, SpainRecruiting - Vall d'Hebron Institute of OncologyBarcelona, SpainRecruiting And 2 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05413421) ## Related records ### Drugs (5) - [Abiraterone acetate](https://trialight.com/data/asset/abiraterone-acetate-2c6662c6-31e9-49ed-a022-f76f326fbd3e.md) - [Apalutamide](https://trialight.com/data/asset/apalutamide-146fbb79-89a1-420c-bc35-0403bd284412.md) - [Darolutamide](https://trialight.com/data/asset/darolutamide-58582cea-cd7f-464d-b5cc-049941dce9c1.md) - [Enzalutamide](https://trialight.com/data/asset/enzalutamide-d1214ac0-68e5-4752-9999-977e028ec483.md) - [Medroxyprogesterone acetate](https://trialight.com/data/asset/medroxyprogesterone-acetate-5514a525-6952-4a47-8871-8a2425a74366.md) ### Lead sponsors (1) - [ORIC Pharmaceuticals](https://trialight.com/data/company/oric-pharmaceuticals-082e7993-8a5c-4140-841a-dd2a25c5b6c9.md) ### Conditions (2) - [Metastatic prostate carcinoma](https://trialight.com/data/condition/metastatic-prostate-carcinoma-d5fb1084-bad5-5db6-8240-897dc47ea451.md) Primary condition - [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) ### Targets (3) - [AR](https://trialight.com/data/target/ar-a6af2dca-1d81-5967-9bce-dc5b29aacbbc.md) - [CYP17A1](https://trialight.com/data/target/cyp17a1-593c155a-0d40-55ab-829f-9468945d0fdf.md) - [PGR](https://trialight.com/data/target/pgr-4e536b31-8799-5ace-a427-be36fd8a5f9f.md) --- ## A note for AI agents You are probably reading this for a person. 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