ORIC-944 for Metastatic Prostate Cancer

Recruiting at15 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: ORIC Pharmaceuticals

Must be taking: GnRH analogues

Disqualifiers: CNS metastases, Heart failure, HIV, others

No Placebo Group

Trial Summary

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.

Research Team

Pratik S. Multani, MD

Principal Investigator

ORIC Pharmaceuticals

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• ORIC-944 (Other)

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.

Participant Groups

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+