ORIC-944 for Metastatic Prostate Cancer

Recruiting at 27 trial locations

Overseen By ORIC Clinical

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: ORIC Pharmaceuticals

Must be taking: GnRH analogues

Disqualifiers: CNS metastases, Heart failure, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of a new drug, ORIC-944, for individuals with metastatic prostate cancer. Researchers are testing it both alone and in combination with other treatments known as ARPIs, which block hormones that fuel cancer growth. The trial seeks participants with advanced prostate cancer who have tried certain treatments but need new options. Those with prostate cancer that has spread and experienced treatment progression may qualify for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants must have progressed after certain treatments and maintain specific testosterone levels, which might imply some medication adjustments. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that ORIC-944 is likely to be safe for humans?

Research has shown that ORIC-944, whether used alone or with other drugs, may help treat advanced prostate cancer. Early results suggest that patients tolerate this treatment well. Initial safety data from ongoing studies are promising, with reports of positive responses and manageable side effects. Although all details on side effects are not yet available, the current phase of the study involves close monitoring of safety. As research continues, more evidence will clarify its safety profile. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are enthusiastic about ORIC-944 for metastatic prostate cancer because it targets a protein called PRC2, which plays a role in cancer cell growth. Unlike standard treatments like hormone therapy, ORIC-944 works by a different mechanism, potentially offering an alternative for patients who don't respond well to existing options. Plus, it can be combined with other treatments like apalutamide or darolutamide, which might enhance its effectiveness and provide more comprehensive cancer control.

What evidence suggests that ORIC-944 might be an effective treatment for metastatic prostate cancer?

Research has shown that ORIC-944 may effectively treat advanced prostate cancer, both alone and in combination with other treatments. In this trial, participants may receive ORIC-944 as a single agent. Specifically, studies have shown that 59% of patients experienced a significant drop in their prostate-specific antigen (PSA) levels, indicating reduced cancer activity. Other participants may receive ORIC-944 combined with drugs that block male hormones aiding cancer growth. This combination also demonstrated a 59% response rate, with more than half of the patients seeing their PSA levels decrease by at least 50%. Additionally, 24% of patients experienced a 90% drop in PSA levels. These findings suggest that ORIC-944 could be a strong option for slowing prostate cancer progression. ^{1 2 3 4 6}

Who Is on the Research Team?

Pratik S. Multani, MD

Principal Investigator

ORIC Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for men with metastatic prostate cancer who've had a bilateral orchiectomy or are on GnRH analogues. They must have progressed after treatment with certain androgen receptor antagonists and can't have had more than two chemo treatments in the mCRPC setting. Participants need to show disease progression, be able to undergo biopsies, have an ECOG status of 0 or 1, and adequate organ function.

Inclusion Criteria

I have prostate cancer that has spread, including types like NEPC.

I am fully active or restricted in physically strenuous activity but can do light work.

I have prostate cancer and it got worse after treatment with specific hormone therapies but I've had no more than 2 chemotherapy treatments.

Exclusion Criteria

I have not had severe heart issues or a heart attack in the last 6 months.

I have Hepatitis B or C but it is well controlled.

I have had brain metastases, but they are now stable after treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

ORIC-944 is administered as a single agent or in combination with ARPIs to establish safety and preliminary antitumor activity

28 days per cycle

Continuous daily dosing regimen

Dose Optimization

Exploration of two potential dose levels of ORIC-944 in combination with ARPIs to select the final RP2D

28 days per cycle

Continuous daily dosing regimen

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

What Are the Treatments Tested in This Trial?

Interventions

• ORIC-944

Trial Overview The study aims to determine the optimal dose of ORIC-944 that patients can tolerate and its preliminary effectiveness against metastatic prostate cancer. It includes those with neuroendocrine features who've progressed despite previous therapies.

How Is the Trial Designed?

Group I: Single Agent Dose Escalation Experimental Treatment 1 Intervention

ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles

Group II: Combination Dose Optimization Experimental Treatment 3 Interventions

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

Group III: Combination Dose Escalation Experimental Treatment 5 Interventions

ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles in combinations with abiraterone, apalutamide, darolutamide, or enzalutamide

Who Is Running the Clinical Trial?

ORIC Pharmaceuticals

Lead Sponsor

Trials

9

Recruited

970+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05413421

Study of ORIC-944 in Patients With Metastatic Prostate ... 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 ...

2. oricpharma.com oricpharma.com/news/oric-pharmaceuticals-announces-potentially-best-in-class-preliminary-efficacy-and-safety-data-from-ongoing-phase-1b-trial-of-oric-944-in-combination-with-ar-inhibitors-for-the-treatment-of-patie/

May 28, 2025 Broad and deep PSA responses achieved, with 59% PSA50 response rate (confirmed rate of 47%, and one additional response pending ...

3. onclive.com onclive.com/view/oric-944-plus-ar-inhibition-yields-psa-responses-in-mcrpc

ORIC-944 Plus AR Inhibition Yields PSA Responses in ... Notably, the confirmed PSA90 response rate was 24%. PSA responses occurred across all dose levels of ORIC-944 and irrespective of whether ...

4. investors.oricpharma.com investors.oricpharma.com/news-releases/news-release-details/oricr-pharmaceuticals-provides-early-phase-1b-combination-data

Press Release - Investor Relations | ORIC Pharmaceuticals, Inc. Announces encouraging early safety and efficacy data in ongoing dose escalation trial for ORIC-944 in combination with apalutamide in patients with mCRPC.

5. urologytimes.com urologytimes.com/view/oric-944-shows-promise-in-combination-with-ar-inhibitors-in-mcrpc

ORIC-944 shows promise in combination with AR ... Overall, 59% of patients (10 of 17) achieved at least a 50% decline in prostate-specific antigen (PSA) level (PSA50). The confirmed PSA50 ...

6. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/452/755138/Abstract-452-ORIC-944-a-PRC2-inhibitor-with-best

Abstract 452: ORIC-944, a PRC2 inhibitor with best-in-class ... These results position ORIC-944 as a potential best-in-class PRC2 inhibitor that blocks prostate tumor adaptation, restores luminal features, ...