A Phase 1 interventional study of ORIC-944 and Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets in Metastatic Prostate Cancer, sponsored by ORIC Pharmaceuticals. Recruiting at 27 sites in 4 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by ORIC Pharmaceuticals · Phase 1, Interventional, and Treatment
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Among 3,595 studies in Prostatic Neoplasms with a site in United States — 607 open to participants now, 977 under way, 101 of them phase 3. Prostatic Neoplasms · United States.
Among the 3,595 studies in Prostatic Neoplasms with a site in United States, this one is the 408th largest by planned enrollment of the 3,023 interventional ones that give a count, is one of 121 that started in 2022, is one of 615 in phase 1, reaches primary completion later than 423 of the 971 other live ones, and was the 2,884th registered.
7,047 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.
Browse Prostatic Neoplasms studies →607 of the 3,595 studies in Prostatic Neoplasms with a site in United States are open now. Recruiting first, the newest first:
City of Hope Medical Center · Sites in United States
Ages 40–80 · Men only
Fred Hutchinson Cancer Center · Sites in United States
Ages 18+ · Men only
University of Michigan Rogel Cancer Center · Sites in United States
Ages 50–75 · Men only · Healthy volunteers
Clinton Bahler · Sites in United States
Ages 18+ · Men only
University of Miami · Sites in United States
Ages 18+ · Men only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
3,595 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 898 · Phase 2 1,383 · Phase 3 321 · Phase 4 50
First in 1988; this study’s year is marked. 121 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 275 is above the median of 60 across 5,349 interventional studies indexed under Prostatic Neoplasms.
Median enrollment 48 across the 3,023 interventional studies, 157 across the 477 observational. Of the 2,355 that completed or were terminated, 997 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
921 of 3,595 have an industry lead sponsor. The 10 most frequent:
ORIC Pharmaceuticals is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
ORIC Pharmaceuticals has 3 studies filed under Prostatic Neoplasms — fewer than ten, so there is no comparison to draw.
338 of the studies in Prostatic Neoplasms with a site in United States that are under way reach primary completion within a year, 25 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03348670Phase 3Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB ChairPharmacogenomics IND Commercial SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms | 2026-11-18 |
| NCT03767244Phase 3Janssen Research & Development, LLCA Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy | 2026-12-01 |
| NCT06970847Phase 3Clarity Pharmaceuticals Ltd64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer | 2026-12-31 |
| NCT02446405Phase 3University of SydneyEnzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer | 2026-12-31 |
| NCT07427043Phase 3Brigham and Women's HospitalRobotic Opioid-free Prostatectomy Enhanced Strategy (ROPES) | 2026-12-31 |
Add all 338 to your calendar (.ics) → With an account.
Among the 3,595 studies in Prostatic Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 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 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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles
Drug: ORIC-944
ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles in combinations with abiraterone, apalutamide, darolutamide, or enzalutamide
Drug: ORIC-944 · Drug: Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets · Drug: Apalutamide (Erleada™) 60 mg or 240 mg tablets · Drug: Darolutamide (Nubeqa®) 300 mg tablets · Drug: Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets
Cohort A and C: ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles in combination with apalutamide Cohort B and D: ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles in combination with darolutamide Combinations with abiraterone or enzalutamide may be conducted in the future
Drug: ORIC-944 · Drug: Apalutamide (Erleada™) 60 mg or 240 mg tablets · Drug: Darolutamide (Nubeqa®) 300 mg tablets
Oral, once daily, continuous
Oral, 1000 mg once daily, continuous
Oral, 240 mg once daily, continuous
Oral, 600 mg twice daily, continuous
Drug page: Enzalutamide
Oral, 160 mg once daily, continuous
Recommended Phase 2 Dose (RP2D)
RP2D as determined by interval 3+3 dose escalation design
Time frame: 12 months
Maximum plasma concentration (Cmax)
PK of ORIC-944 single agent and in combination with an ARPI
Time frame: 28 Days
Time to maximum observed concentration (Tmax)
PK of ORIC-944 single agent and in combination with an ARPI
Time frame: 28 Days
Area under the curve (AUC)
PK of ORIC-944 single agent and in combination with an ARPI
Time frame: 28 Days
Apparent plasma terminal elimination half-life (t1/2)
PK of ORIC-944 single agent and in combination with an ARPI
Time frame: 28 Days
Clinical benefit rate (CBR)
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: 36 months
Objective response rate (ORR)
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: 36 months
Duration of response (DOR)
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: 36 months
Progression-free survival (PFS)
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: 36 months
On-treatment PSA levels and change from baseline
Prostate cancer working group 3 criteria (PCWG3)
Time frame: 36 months
Started Jun 2022 (actual). Primary completion is estimated for Jun 2027, 60 months after the start.
Of 212 industry-sponsored phase 1 interventional studies under Prostatic Neoplasms, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 62. This study's planned 60 months is above that.
Counting every sponsor, half of 456 studies reached it within 43 months; a quarter within 23 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
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ORIC Pharmaceuticals