Active Cancer NIHR-supported project Digestion, Kidneys & Other Organs

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

Funder NIHR (part of DHSC)
Recipient organisation NIHR Royal Marsden Clinical Research Facility
NIHR support Recorded as supported by this research centre
Period Mar 2025 — Apr 2028

In plain English

AI plain-English summary

A new drug, ORIC-944, is being tested for the first time in humans to treat metastatic prostate cancer that has spread beyond the prostate. This matters because prostate cancer is the most common cancer in men, and when it spreads, it becomes harder to treat. Current treatments include androgen receptor pathway inhibitors (ARPIs) like darolutamide, but cancers often stop responding over time. ORIC-944 is designed to block a different target inside cancer cells, potentially overcoming resistance to existing therapies. The UK is participating in Part III of this early-stage trial, which tests two doses of ORIC-944 combined with darolutamide in 28-day cycles until the disease progresses or side effects become intolerable. If this research succeeds, it could provide a new treatment option for men with metastatic prostate cancer whose disease has progressed on standard therapies. The study also examines how food affects drug absorption, which could simplify dosing instructions for patients. However, this is an early-phase trial focused on safety, tolerability, and blood levels of the drug—not yet on proving clinical benefit. Success here would only justify larger trials to determine whether ORIC-944 actually extends survival or delays progression.

View original technical description
Prostate Cancer is the most common cancer in men. If the cancer spreads to other areas, this is known as metastases. The treatment being investigated in this study is ORIC-944. This is the first time ORIC-944 is being administered to humans. Several doses of ORIC-944 will be tested. The research study consists of 3 parts:Part I: dose finding portion for ORIC-944 when administered as a single drug. This part of the study is complete.Part II: dose finding portion for ORIC-944 when administered in combination with apalutamide (Erleada™) or darolutamide (Nubeqa®), 2 different approved Androgen Receptor Pathway Inhibitor (ARPI), drugs that are used to treat prostate cancer. Part III: will further test 2 potential dose levels of ORIC-944 selected from Part II in combination with darolutamide to select the most tolerable and safe active dose.Additionally, a food effect sub-study is also being conducted to explore the effect of food on the amount of ORIC-944 absorbed by the body and its safety.The UK is participating in Part III of the study only. Darolutamide will be the ARPI provided in the UK.The primary purposes of Part III are to further evaluate the safety, tolerability, and activity of the 2 potential doses of ORIC-944 in combination with darolutamide, that were selected from Part II and to measure the amount to ORIC-944 in the participant’s blood when co-administered with darolutamide.Study treatment is based on daily dosing in 28-day treatment cycles until disease progression, if the treatment becomes intolerable or the participant withdraws consent.

Researchers

Johann De Bono (Principal Investigator)

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