250 Participants Needed

ORIC-944 for Metastatic Prostate Cancer

Recruiting at 15 trial locations
OC
Overseen ByORIC Clinical
Age: 18+
Sex: Male
Trial Phase: Phase 1
Sponsor: ORIC Pharmaceuticals
Must be taking: GnRH analogues
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Who Is on the Research Team?

PS

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.
See 5 more

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.
See 3 more

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?
3Treatment groups
Experimental Treatment
Group I: Single Agent Dose EscalationExperimental Treatment1 Intervention
Group II: Combination Dose OptimizationExperimental Treatment3 Interventions
Group III: Combination Dose EscalationExperimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

ORIC Pharmaceuticals

Lead Sponsor

Trials
9
Recruited
970+
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