ClinicalTrials.gg
CompletedNCT05227144Updated Mar 20, 2025

Study of ORIC-533 in Relapsed or Refractory Multiple Myeloma

A Phase 1 interventional study of ORIC-533 in Relapsed or Refractory Multiple Myeloma, sponsored by ORIC Pharmaceuticals. Completed at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-20.

Primary conditionMultiple MyelomaRegistry: RecurrenceReclassifiedWhy we changed it
Registry
Recurrence — the first condition term the registry derived for this study.
ClinicalTrials.gg
Multiple Myeloma
Why
  1. Recurrence describes something many studies share rather than a condition a study is about.
  2. The study's listed conditions name Multiple Myeloma.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by ORIC Pharmaceuticals · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Mar 2025, 1 year 8 months ago, and no results have been posted to the registry.

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Phase
Phase 1
Study type
Interventional
Enrollment
31
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 2,168 studies in Multiple Myeloma with a site in United States — 275 open to participants now, 503 under way, 66 of them phase 3. Multiple Myeloma · United States.

Enrollment
1,057th of 1,901
31 · median 36
Started
2022
with 93 others
Phase 1
559 of 2,168
64 open now
Registered
1,805th of 2,168
by date

Among the 2,168 studies in Multiple Myeloma with a site in United States, this one is the 1,057th largest by enrollment of the 1,901 interventional ones that give a count, is one of 94 that started in 2022, is one of 559 in phase 1, and was the 1,805th registered.

Multiple Myeloma

3,763 studies on the registry are indexed under Multiple Myeloma; 770 are open to participants now.

Browse Multiple Myeloma studies →

Open to participants now

275 of the 2,168 studies in Multiple Myeloma with a site in United States are open now. Recruiting first, the newest first:

270 more — sign in →

All 275 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 585 Multiple Myeloma studies recruiting now, 430 (74%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 2,168 studies in Multiple Myeloma with a site in United States, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Relapsed or Refractory Multiple Myeloma

Browse trials for

Keywords

  • CD73
04

In context

Multiple Myeloma Reclassified

3,763 studies on the registry are indexed under Multiple Myeloma; 770 are open to participants now.

This study's enrollment of 31 is below the median of 41 across 3,008 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

ORIC Pharmaceuticals is the lead sponsor of 10 studies on the registry; 4 are open to participants now.

Compared within Multiple Myeloma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of multiple myeloma (MM) with 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
  • 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)
    • Measurable bone or extramedullary plasmacytoma
  • performance status ≤2
  • Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as:

    • Estimated ≥40 mL/min/1.73 m2.
    • (ALT) and aspartate aminotransferase (AST) levels both ≤3 times of , unless there is suspected disease in the liver, in which case, no limit is set provided serum is within eligibility criterion
    • Total bilirubin \<1.5 × upper limit of normal (ULN), except in study participants with Gilbert's syndrome
    • count >40,000/μL
    • (ANC) >1000/μL
    • (LVEF) >45% as assessed by echocardiogram (ECHO) or multiple gated acquisition (MUGA)
    • Baseline oxygen saturation >92% on room air

Exclusion criteria

Exclusion Criteria:

  • Diagnosed or treated for another 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 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
  • 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 (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 (HIV), (HBV), or 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
  • >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
Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

06

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Dose Escalation

    ORIC-533 dosed orally, once per day of each consecutive 28-day cycle.

    Drug: ORIC-533

  • Experimental
    Dose Expansion

    RP2D dose

    Drug: ORIC-533

Interventions

  • DrugORIC-533

    ORIC-533 once daily in consecutive 28-day cycles

07

What researchers measure

Primary outcomes

  1. Recommended Phase 2 Dose (RP2D)

    RP2D as determined by interval 3+3 dose escalation design

    Time frame: 12 months

  2. Number of participants with adverse events

    Safety and tolerability of ORIC-533

    Time frame: 36 months

  3. Number of participants with abnormal laboratory

    Safety and tolerability of ORIC-533

    Time frame: 36 months

Secondary outcomes

  1. Maximum plasma concentration (Cmax)

    PK of ORIC-533

    Time frame: 28 Days

  2. Area under the curve last concentration (AUClast)

    PK of ORIC-533

    Time frame: 28 Days

  3. Elimination half-life (t1/2)

    PK of ORIC-533

    Time frame: 28 Days

08

Study locations

8 sites
  • James R. Berenson, MD, Inc.
    West Hollywood, California 90069, United States
  • Northside Hospital Cancer Institute
    Atlanta, Georgia 30342, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • Mayo Clinical Rochester
    Rochester, Minnesota 55905, United States
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
  • The Charlotte-Mecklenburg Hospital Authority d/b/a Atrium Health
    Charlotte, North Carolina 28203, United States
  • Swedish Health Services
    Seattle, Washington 98107, United States
  • Princess Margaret Cancer Research Center/University Health Network
    Toronto, Ontario, Canada
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2022 to primary completion in Mar 2025, 37 months.

Of 212 industry-sponsored phase 1 interventional studies under Multiple Myeloma, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 71. This study's 37 months is below that.

Counting every sponsor, half of 413 studies reached it within 50 months; a quarter within 33 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 2, 2022
First posted
Feb 7, 2022
StartActual
Jan 6, 2022
Primary completionActual
Mar 3, 2025
CompletionActual
Mar 3, 2025
Last update
Mar 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05227144
Lead sponsor
ORIC Pharmaceuticals
Responsible party
Sponsor
First posted
Feb 7, 2022
Start date
Jan 6, 2022
Primary completion
Mar 3, 2025
Completion
Mar 3, 2025
Last update
Mar 20, 2025

Study contacts

Pratik S. Multani, MD
study director · ORIC Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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