Relapsed or Refractory Multiple MyelomaPhase 1NCT05227144
Study of ORIC-533 in Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing ORIC-533 in people with Relapsed or Refractory Multiple Myeloma, run by ORIC Pharmaceuticals at 8 sites in 2 countries.
Trial summary
The purpose of this study is to establish the Recommended Phase 2 Dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antimyeloma activity of ORIC-533 in patients with multiple myeloma who have exhausted available treatment options Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- ORIC-533
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 6 Jan 2022to 3 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of multiple myeloma (MM) with relapsed or refractory disease according to IMWG Criteria
- 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
- Measurable disease at screening, including at least 1 of the criteria below:
- Serum M-protein >0.5 g/dL (Patients with IgA myeloma in whom serum M protein is unreliable due to comigration of normal serum proteins may be considered eligible if total IgA >400 mg/dL)
- Urine M-protein >200 mg/24 hours
- Serum free light chains (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65)
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- Measurable bone or extramedullary plasmacytoma
- ECOG performance status ≤2
- Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as:
- Estimated glomerular filtration rate ≥40 mL/min/1.73 m2.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels both ≤3 times of upper limit of normal, unless there is suspected disease in the liver, in which case, no limit is set provided serum bilirubin is within eligibility criterion
- Total bilirubin <1.5 × upper limit of normal (ULN), except in study participants with Gilbert's syndrome
- Platelet count >40,000/μL
- Absolute neutrophil count (ANC) >1000/μL
- Left ventricular ejection fraction (LVEF) >45% as assessed by echocardiogram (ECHO) or multiple gated acquisition (MUGA)
- Baseline oxygen saturation >92% on room air
Who cannot join
- Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy
- Previous or concurrent plasma cell leukemia, AL amyloidosis, or POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome
- Known central nervous system (CNS) involvement
- Evidence of hyperviscosity syndrome
- Receiving any investigational treatment with a novel investigational agent (ie, no approved indication) within 28 days prior to the first dose of study drug
- Not recovered or stabilized from all toxicities from prior anticancer therapies and/or radiotherapy to Grade <2 with the exception of peripheral neuropathy
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- Major surgery or radiation therapy within 14 days prior to first dose of study drug or incomplete recovery from adverse effects resulting from such procedure
- Those who require limited course of radiation for management of bone pain for ≤14 days from initiation of therapy are not excluded
- Infection requiring systemic antibiotic therapy or other serious infection within 14 days of starting therapy
- Those who are on prophylactic antibiotics only, or on antibiotics and have confirmation of resolution of active infection, are eligible
- Daily requirement for corticosteroids (equivalent to >10 mg/day prednisone). Inhalation corticosteroids are exempt from this criterion
- Exception: Corticosteroid dose equivalent >10 mg/day prednisone is acceptable if physiological levels require, so long as the dose is stable for at least 7 days prior to initiation of therapy
- Lower amounts of corticosteroids that are not part of a daily requirement within 14 days prior to initiating therapy are also acceptable
- Known seropositive for active viral infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV). Those who are seropositive because of hepatitis B vaccine are eligible. Patients who are positive for HBV core antibody or HBV surface antigen must have a negative polymerase chain reaction (PCR) result prior to enrollment. Those who are PCR positive will be excluded.
- History of class III or IV congestive heart failure or severe non-ischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months of first dose of study drug
- QTcF >470 msec
- Other concurrent serious uncontrolled medical, psychological, or addictive conditions that, in the opinion of the investigator, may interfere with protocol compliance or contraindicates participation in the study
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Northside Hospital Cancer Institute
Atlanta, Georgia, 30342
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
The Charlotte-Mecklenburg Hospital Authority d/b/a Atrium Health
Charlotte, North Carolina, 28203
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Mayo Clinical Rochester
Rochester, Minnesota, 55905
Swedish Health Services
Seattle, Washington, 98107
James R. Berenson, MD, Inc.
West Hollywood, California, 90069
Canada1 site
Princess Margaret Cancer Research Center/University Health Network
Toronto, Ontario
About this study
Official title: An Open-label Phase 1b Study of ORIC-533 in Patients With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to establish the Recommended Phase 2 Dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antimyeloma activity of ORIC-533 in patients with multiple myeloma who have exhausted available treatment options
Read the detailed description
ORIC-533 is a selective, orally bioavailable, small molecule inhibitor of CD73.This is an open-label, uncontrolled, multicenter, dose-finding study to assess the safety and preliminary antimyeloma activity of ORIC-533 in patients with relapsed or refractory multiple myeloma.
After the RP2D has been determined, dose expansion will further evaluate safety and preliminary antimyeloma activity of ORIC-533 in patients with relapsed or refractory multiple myeloma.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- ORIC-533
- Keywords
- CD73
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORIC-533Drug
ORIC-533 once daily in consecutive 28-day cycles
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | ORIC-533 dosed orally, once per day of each consecutive 28-day cycle. Receives: Drug: ORIC-533 |
| Dose Expansion | Experimental | RP2D dose Receives: Drug: ORIC-533 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose (RP2D)
RP2D as determined by interval 3+3 dose escalation design
Measured: 12 months
Number of participants with adverse events
Safety and tolerability of ORIC-533
Measured: 36 months
Number of participants with abnormal laboratory
Safety and tolerability of ORIC-533
Measured: 36 months
Secondary outcomes (3)
Maximum plasma concentration (Cmax)
PK of ORIC-533
Measured: 28 Days
Area under the curve last concentration (AUClast)
PK of ORIC-533
Measured: 28 Days
Elimination half-life (t1/2)
PK of ORIC-533
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start6 Jan 2022
- Primary completion3 Mar 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Interval 3+3 dose escalation design, followed by dose expansion
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- ORIC Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pratik S. Multani, MD, Study director, ORIC Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227144
- Sponsor's protocol ID
- ORIC-533-01
- Status last verified
- Mar 2025
- First submitted
- 2 Feb 2022
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase 1b Study of ORIC-533 in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05227144
- Acronym / sponsor ID
- ORIC-533-01
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Keywords
- CD73
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- ORIC PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to establish the Recommended Phase 2 Dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antimyeloma activity of ORIC-533 in patients with multiple myeloma who have exhausted available treatment options
Detailed description
ORIC-533 is a selective, orally bioavailable, small molecule inhibitor of CD73.This is an open-label, uncontrolled, multicenter, dose-finding study to assess the safety and preliminary antimyeloma activity of ORIC-533 in patients with relapsed or refractory multiple myeloma.
After the RP2D has been determined, dose expansion will further evaluate safety and preliminary antimyeloma activity of ORIC-533 in patients with relapsed or refractory multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interval 3+3 dose escalation design, followed by dose expansion
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: ORIC-533ORIC-533 dosed orally, once per day of each consecutive 28-day cycle. |
| Dose Expansion | Experimental | Drug: ORIC-533RP2D dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Diagnosis of multiple myeloma (MM) with relapsed or refractory disease according to IMWG Criteria
- 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
- Measurable disease at screening, including at least 1 of the criteria below:
- ECOG performance status ≤2
- Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as:
Key exclusion criteria (17 listed)
- Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy
- Previous or concurrent plasma cell leukemia, AL amyloidosis, or POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome
- Known central nervous system (CNS) involvement
- Evidence of hyperviscosity syndrome
- Receiving any investigational treatment with a novel investigational agent (ie, no approved indication) within 28 days prior to the first dose of study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORIC-533ORIC-533 once daily in consecutive 28-day cycles | Drug | Dose Escalation, Dose Expansion |
Primary outcome
Recommended Phase 2 Dose (RP2D)
Time frame: 12 months
RP2D as determined by interval 3+3 dose escalation design
Number of participants with adverse events
Time frame: 36 months
Safety and tolerability of ORIC-533
Number of participants with abnormal laboratory
Time frame: 36 months
Safety and tolerability of ORIC-533
3 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: 28 Days
Area under the curve last concentration (AUClast)
Time frame: 28 Days
Elimination half-life (t1/2)
Time frame: 28 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pratik S. Multani, MD study director
ORIC Pharmaceuticals
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ORIC-533 in people with Relapsed or Refractory Multiple Myeloma, run by ORIC Pharmaceuticals at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase 2 Dose (RP2D) (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.