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Small Molecule Inhibitor
ORIC-533 for Multiple Myeloma
Phase 1
Recruiting
Research Sponsored by ORIC Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≤2
Refractory to or not eligible for MM treatment regimens known to provide clinical benefit, including but not limited to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, with documented disease progression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
Study Summary
This trial is testing a new drug for patients with multiple myeloma who have run out of other treatment options. They will establish a safe dose and look at how the drug works in the body.
Who is the study for?
This trial is for adults with multiple myeloma that's come back or hasn't responded to treatment. They should have tried treatments like immunomodulators, proteasome inhibitors, and anti-CD38 antibodies without success. Participants need good heart, lung, liver, kidney function and a certain level of blood cells. People can't join if they've had major surgery recently, other cancers in the last 3 years (with some exceptions), severe heart issues in the past 6 months, active infections or certain chronic conditions.Check my eligibility
What is being tested?
The study tests ORIC-533 on patients whose multiple myeloma has relapsed or is refractory after standard treatments failed. It aims to find out the safest dose that works (RP2D), how it affects the body (PK/PD), and its effectiveness against cancer cells.See study design
What are the potential side effects?
While specific side effects of ORIC-533 are not listed here, common ones for new cancer drugs may include nausea, fatigue, risk of infection due to low blood cell counts, liver problems indicated by changes in enzyme levels and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
My multiple myeloma has not responded to standard treatments, including immunotherapy, proteasome inhibitors, and anti-CD38.
Select...
My multiple myeloma has come back or is not responding to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with abnormal laboratory
Number of participants with adverse events
Recommended Phase 2 Dose (RP2D)
Secondary outcome measures
Area under the curve last concentration (AUClast)
Elimination half-life (t1/2)
Maximum plasma concentration (Cmax)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment1 Intervention
RP2D dose
Group II: Dose EscalationExperimental Treatment1 Intervention
ORIC-533 dosed orally, once per day of each consecutive 28-day cycle.
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Who is running the clinical trial?
ORIC PharmaceuticalsLead Sponsor
7 Previous Clinical Trials
583 Total Patients Enrolled
Pratik S. Multani, MDStudy DirectorORIC Pharmaceuticals
3 Previous Clinical Trials
215 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to my brain or spinal cord.I can take care of myself but might not be able to do heavy physical work.I have not needed antibiotics for a serious infection in the last 14 days.Your platelet count is higher than 40,000 per microliter.You have signs of thickened blood.Your heart takes longer than normal to recharge between beats.My side effects from previous cancer treatments have mostly gone away or are manageable.You have a disease that can be measured during the screening process.My multiple myeloma has not responded to standard treatments, including immunotherapy, proteasome inhibitors, and anti-CD38.Your heart's pumping ability, as measured by a special heart test, is greater than 45%.I do not have an active HIV, HBV, or HCV infection, or if I have HBV, my PCR test is negative.I have had or currently have plasma cell leukemia, AL amyloidosis, or POEMS syndrome.I haven't had severe heart issues or a heart attack in the last 6 months.Your kidneys are working well enough, with a filtration rate of at least 40 mL/min/1.73 m2.My multiple myeloma has come back or is not responding to treatment.Your oxygen level is over 92% when breathing normally.I haven't had cancer, except for certain skin cancers or low-risk prostate cancer treated over 3 years ago.My liver enzymes are within normal limits, or if I have liver disease, my bilirubin levels are still acceptable.I haven't had major surgery or radiation within the last 2 weeks.I take more than 10 mg/day of corticosteroids, not including inhalers.My heart, lungs, liver, kidneys, and bone marrow are working well.Your bilirubin levels should be within a certain range, unless you have Gilbert's syndrome.You have a low number of a type of white blood cell called neutrophils.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation
- Group 2: Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are the researchers currently recruiting participants for this research project?
"Affirmative. Clinicaltrials.gov records indicate that this clinical trial, which was first posted on June 1st 2022 is currently in the process of patient recruitment. The research team needs to recruit 48 volunteers across 2 sites for further study participation."
Answered by AI
How many participants will this clinical trial involve?
"Affirmative. Clinicaltrials.gov data reveals that this trial, posted on January 6th 2022 and last updated February 2nd 2022, is actively recruiting candidates. The study requires 48 patients from two distinct sites to participate."
Answered by AI
What are the attendant risks of utilizing ORIC-533 to treat patients?
"Due to the early stage of clinical trials, ORIC-533's safety has been provisionally assessed as a 1. This is reflective of limited data that supports its efficacy and protection from harm."
Answered by AI
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