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ORIC-533

Phase 1

Relapsed or Refractory Multiple Myeloma | Small molecule | Oncology |Oric Pharmaceuticals, Inc.|Last Updated: Mar 20, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

ORIC-533 · 1 trial · 1 indication

Phase 1 1
NCT05227144Study of ORIC-533 in Relapsed or Refractory Multiple MyelomaRelapsed or Refractory Multiple Myeloma
COMPLETED31 Analytics
PHASE1COMPLETED
Study of ORIC-533 in Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Recommended Phase 2 Dose (RP2D)
12 months

RP2D as determined by interval 3+3 dose escalation design

Number of participants with adverse events
36 months

Safety and tolerability of ORIC-533

Number of participants with abnormal laboratory
36 months

Safety and tolerability of ORIC-533

Secondary Endpoints

Maximum plasma concentration (Cmax)
28 Days
Area under the curve last concentration (AUClast)
28 Days
Elimination half-life (t1/2)
28 Days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose EscalationEXPERIMENTALORIC-533 dosed orally, once per day of each consecutive 28-day cycle.
Dose ExpansionEXPERIMENTALRP2D dose

Interventions

NameTypeDescription
ORIC-533DRUGORIC-533 once daily in consecutive 28-day cycles
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

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...

Countries:United StatesCanada
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Competitive Landscape -Multiple Myeloma 221 trials (matched to "Relapsed or Refractory Multiple Myeloma")

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax
Bristol-Myers Squibb CompanyBMY18PHASE3Iberdomide, Lenalidomide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Johnson & JohnsonJNJ28PHASE3Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone
Regeneron Pharmaceuticals, Inc.REGN11PHASE3Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Pfizer Inc.PFE11PHASE3Elranatamab, Lenalidomide
Sanofi SA Sponsored ADRSNY17PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol/ Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040/kg, G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
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Frequently asked questions about ORIC-533

What is ORIC-533 used for?

ORIC-533 is an investigational small molecule being studied for the treatment of relapsed or refractory multiple myeloma, a type of blood cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing ORIC-533?

ORIC-533 is being developed by Oric Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ORIC. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is ORIC-533 in?

ORIC-533 is in Phase 1 clinical development. A Phase 1 study of ORIC-533 in relapsed or refractory multiple myeloma has been completed, involving 31 participants. The drug remains investigational and is not yet approved for any use.

What clinical trials is ORIC-533 in?

ORIC-533 has been studied in a Phase 1 clinical trial identified as NCT05227144, titled 'Study of ORIC-533 in Relapsed or Refractory Multiple Myeloma.' This trial enrolled 31 participants and was conducted in the United States and Canada. The trial has been completed.

Is ORIC-533 FDA approved?

ORIC-533 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for relapsed or refractory multiple myeloma. A completed Phase 1 trial has evaluated its safety and tolerability, but it has not yet received regulatory approval.