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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment31
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05227144Study of ORIC-533 in Relapsed or Refractory Multiple MyelomaPHASE1 COMPLETED 31Jan 6, 2022Mar 3, 2025Mar 20, 20258 United States, Canada
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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 — 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 228 trials
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