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ORIC-114

Phase 1

Solid Tumors | Small molecule | Oncology |Oric Pharmaceuticals, Inc.|Last Updated: Aug 5, 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 Enrollment350
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05315700Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 AlterationPHASE1 RECRUITING 350Mar 10, 2022Sep 1, 2027Aug 5, 202542 United States, Australia +8
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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

Maximum plasma concentration (Cmax)
28 Days

PK of ORIC-114

Time of maximum observed concentration (Tmax)
28 Days

PK of ORIC-114

Area under the curve (AUC)
28 Days

PK of ORIC-114

Apparent plasma terminal elimination half-life (t1/2)
28 Days

PK of ORIC-114

Secondary Endpoints
Objective response rate (ORR)
36 months
Duration of response (DOR)
36 months
Clinical benefit rate (CBR)
36 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Escalation and Dose OptimizationEXPERIMENTALORIC-114 dosed orally on a continuous once daily dosing regimen in 28-day cycles.
Combination Dose EscalationEXPERIMENTALORIC-114 dosed orally on a continuous once daily dosing regimen in 21-day cycles.
Interventions
NameTypeDescription
ORIC-114DRUGORIC-114 oral daily
Chemotherapy drugDRUG21 days for up to 4 cycles
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites42

Inclusion Criteria: * Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented EGFR or HER2 exon 20 insertion mutation or atypical EGFR mutation as determined by any nucleic acid-based diagnostic testing method, or HER2 amplification/overexpression as d...

Countries:United StatesAustraliaCanadaHong KongMalaysiaPolandSouth KoreaSpainTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05315700primaryCompletionDate: changed
LOWMay 24, 2026NCT05315700studyFirstPostDate: changed