ORIC-944 for Malignant Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Karmanos, Detroit, MI
Malignant Neoplasms+2 More
ORIC-944 - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to treat prostate cancer that has spread. They are testing to see what dose is safe and effective. The ORIC-944 drug is used to treat cancerous tumors and there is no placebo group in this trial, meaning all patients will receive the treatment. ORIC-944 has been previously approved by the FDA for another condition, so its safety is already known. This treatment is free of charge.

Eligible Conditions

  • Malignant Neoplasms
  • Neuroendocrine Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Malignant Neoplasms

Study Objectives

5 Primary · 4 Secondary · Reporting Duration: 36 months

12 months
Recommended Phase 2 Dose (RP2D)
28 Days
Apparent plasma terminal elimination half-life (t1/2)
Area under the curve (AUC)
Maximum plasma concentration (Cmax)
Time to maximum observed concentration (Tmax)
36 months
Clinical benefit rate (CBR)
Duration of response (DOR)
Objective response rate (ORR)
Progression-free survival (PFS)

Trial Safety

Safety Progress

1 of 3

Other trials for Malignant Neoplasms

Trial Design

1 Treatment Group

Dose Escalation
1 of 1
Experimental Treatment

42 Total Participants · 1 Treatment Group

Primary Treatment: ORIC-944 · No Placebo Group · Phase 1

Dose Escalation
Drug
Experimental Group · 1 Intervention: ORIC-944 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months
Closest Location: Karmanos · Detroit, MI
Photo of karmanos cancer institute 1Photo of Karmanos Cancer Institute 2Photo of mi barbara ann karmanos cancer institute 3
2020First Recorded Clinical Trial
0 TrialsResearching Malignant Neoplasms
1 CompletedClinical Trials

Who is running the clinical trial?

ORIC PharmaceuticalsLead Sponsor
6 Previous Clinical Trials
410 Total Patients Enrolled
Pratik S. Multani, MDStudy DirectorORIC Pharmaceuticals
3 Previous Clinical Trials
312 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have undergone bilateral orchiectomy or are willing to continue GnRH analogue or antagonist to maintain castrate levels of testosterone.
You have a history of progressive disease by PCWG3 criteria for study entry.
You have no symptoms or signs of cancer.
You have adequate organ function.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.