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REC-1245

Phase 1

Unresectable | Small molecule | Oncology |Recursion Pharmaceuticals, Inc.|Last Updated: May 8, 2026

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment170
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06678659A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic CancerPHASE1 RECRUITING 170 — — Nov 21, 2024Oct 30, 2028May 8, 20266 United States, Canada
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Study Endpoints
Primary Endpoints
Phase 1-Part 1A (Dose Finding)- Number of Participants With Dose Limiting Toxicities (DLTs)
Initiation of study drug through 4 weeks

To characterize the incidence of DLTs

Phase 1 and 2 - Number of Participants With a Treatment-emergent Adverse Event
Initiation of study drug through 30 days after the last dose (up to approximately 24 months)

To characterize the incidence of treatment emergent adverse events

Phase 2- Objective Response Rate (ORR)
Initiation from study drug until disease progression (up to approximately 24 months)

To assess tumor response

Secondary Endpoints
Phase 1- ORR
Initiation from study drug until disease progression (up to approximately 24 months)
Phase 1 and 2- Disease Control Rate (DCR)
Initiation from study drug until disease progression as applicable (up to approximately 24 months)
Phase 1 and 2 - Duration of Response (DOR)
Initiation from study drug until disease progression as applicable (up to approximately 24 months)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1aEXPERIMENTALDose Finding
Phase 1b Cohort AEXPERIMENTAL -
Phase 1b Cohort BEXPERIMENTAL -
Phase 1b Cohort CEXPERIMENTAL -
Phase 1b Cohort DEXPERIMENTAL -
Phase 2 Cohort 1 Dose #1EXPERIMENTAL -
Phase 2 Cohort 1 Dose #2EXPERIMENTAL -
Phase 2 Cohort 2 Dose #1EXPERIMENTAL -
Phase 2 Cohort 2 Dose #2EXPERIMENTAL -
Interventions
NameTypeDescription
REC-1245DRUGOral
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Have histologically-confirmed unresectable, locally advanced, or metastatic select solid tumors or select relapsed / refractory lymphoma * Have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatme...

Countries:United StatesCanada
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06678659Enrollment: 85 → 170
LOWMay 24, 2026NCT06678659studyFirstPostDate: changed