Ph 1 Study of ORIC-944 in Patients with Metastatic Prostate Cancer
Research type
Research Study
Full 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
IRAS ID
1010957
Contact name
Alison Huang
Contact email
Sponsor organisation
ORIC Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
Research summary
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.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
24/EE/0280
Date of REC Opinion
30 Jan 2025
REC opinion
Further Information Favourable Opinion