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Study of ORIC-533 in Relapsed or Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05227144
Recruitment Status : Recruiting
First Posted : February 7, 2022
Last Update Posted : February 7, 2022
Sponsor:
Information provided by (Responsible Party):
ORIC Pharmaceuticals

Brief 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

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Multiple Myeloma Drug: ORIC-533 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Interval 3+3 dose escalation design, followed by dose expansion
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase 1b Study of ORIC-533 in Patients With Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : January 6, 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Dose Escalation
ORIC-533 dosed orally, once per day of each consecutive 28-day cycle.
Drug: ORIC-533
ORIC-533 once daily in consecutive 28-day cycles

Experimental: Dose Expansion
RP2D dose
Drug: ORIC-533
ORIC-533 once daily in consecutive 28-day cycles




Primary Outcome Measures :
  1. Recommended Phase 2 Dose (RP2D) [ Time Frame: 12 months ]
    RP2D as determined by interval 3+3 dose escalation design

  2. Number of participants with adverse events [ Time Frame: 36 months ]
    Safety and tolerability of ORIC-533

  3. Number of participants with abnormal laboratory [ Time Frame: 36 months ]
    Safety and tolerability of ORIC-533


Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: 28 Days ]
    PK of ORIC-533

  2. Area under the curve last concentration (AUClast) [ Time Frame: 28 Days ]
    PK of ORIC-533

  3. Elimination half-life (t1/2) [ Time Frame: 28 Days ]
    PK of ORIC-533



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
    • Measurable bone or extramedullary plasmacytoma
  • ECOG performance status ≤2
  • Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as:

    • Estimated glomerular filtration rate ≥60 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 >50,000/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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05227144


Contacts
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Contact: Jennifer Gillespie 650-388-5600 jennifer.gillespie@oricpharma.com
Contact: Edna Chow Maneval, PhD 650-388-5600 edna.chowmaneval@oricpharma.com

Locations
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United States, California
James R. Berenson, MD, Inc. Recruiting
West Hollywood, California, United States, 90069
Contact: Regina Swift    310-623-1228    rswift@berensoncancercenter.com   
Principal Investigator: James R. Berenson, MD         
United States, Minnesota
Mayo Clinical Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Melanie Thompson    507-284-4726    thompson.melanie@mayo.edu   
Principal Investigator: Wilson Gonsalves, MD         
Sponsors and Collaborators
ORIC Pharmaceuticals
Investigators
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Study Director: Pratik S. Multani, MD ORIC Pharmaceuticals
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Responsible Party: ORIC Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05227144    
Other Study ID Numbers: ORIC-533-01
First Posted: February 7, 2022    Key Record Dates
Last Update Posted: February 7, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ORIC Pharmaceuticals:
CD73
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases