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177Lu girentuximab

Phase 1

Advanced Cancer | Small molecule | Oncology |Telix Pharmaceuticals Limited|Last Updated: May 5, 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
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05663710Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCCPHASE1 RECRUITING 100Jun 30, 2023Oct 30, 2027May 5, 20261 United States
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Study Endpoints
Primary Endpoints
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
through study completion; an average of 1 year
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1 (Biopsy)EXPERIMENTALParticipants within 2 weeks of starting the first dose of 177Lu-girentuximab
Cohort 2 (Biopsy)EXPERIMENTALParticipants within 2 weeks of Cycle 4
Cohort 3 (Biopsy)EXPERIMENTALParticipants at the time of progression or at 20 months post treatment
Interventions
NameTypeDescription
177Lu girentuximabDRUGGiven by IV (vein)
NivolumabDRUGGiven by IV (vein)
CabozantinibDRUGGiven by PO
ArabinoFuranosylGuanine [18F]F-AraGDRUGGiven by IV (vein)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Has the ability to understand and willingness to sign a written ICF before the performance of any study-specific procedures on this protocol and 2022-0515 2. Age ≥ 18 years 3. Has locally advanced or metastatic RCC with predominantly clear cell subtype 4. Has at least one mea...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05663710primaryCompletionDate: changed
LOWMay 24, 2026NCT05663710studyFirstPostDate: changed