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TRX518

Phase 1

Unresectable Stage III or Stage IV Malignant Melanoma or Other Solid Tumor Malignancies | Monoclonal antibody | Oncology |Cypherpunk Technologies Inc.|Last Updated: Aug 3, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01239134Trial of TRX518 (Anti-GITR mAb) in Stage III or IV Malignant Melanoma or Other Solid TumorsPHASE1 COMPLETED 10Oct 1, 2010Sep 1, 2018Aug 3, 20251 United States
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Study Endpoints
Primary Endpoints
Part A: Adverse Events
through 30 days post last dose

Any adverse change in health or side effect from the initiation of the study drug dose through completion or premature withdrawal

Part A: TRX518 peak concentration (Cmax)
various timepoints through 1 week post dose

Observations of the distribution, duration of effects and chemical changes of TRX518 in the body and the effects and routes of the body's elimination of TRX518

Part A: Time to peak concentration (Tmax)
various timepoints through 1 week post dose

Observations of the distribution, duration of effects and chemical changes of TRX518 in the body and the effects and routes of the body's elimination of TRX518

Part A: Area under the curve (AUC)
various timepoints through 1 week post dose

Observations of the distribution, duration of effects and chemical changes of TRX518 in the body and the effects and routes of the body's elimination of TRX518

Part A: Define a maximum single dose at which there are tolerable side effects and/or maximum PK/PcD parameter changes
End of Cycle 1 (Day 28)
Parts B and C: Adverse Events
through 30 days post dose

Any adverse change in health or side effect from the initiation of the study drug dose through completion or premature withdrawal

Secondary Endpoints
Part A: Evaluate the effect of TRX518 on lymphoid cell subset number and function
At baseline and at various timepoints up to 6 weeks post dose
Part A: Assess TRX518 immunogenicity
At baseline and at various timepoints up to 18 weeks post dose
Part A: Evaluate the effect of TRX518 on long-term safety measuring vital signs, tumor status, adverse events
At Months 6, 12, 18 and 24
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TRX518EXPERIMENTAL -
Interventions
NameTypeDescription
TRX518BIOLOGICALHumanized, Fc disabled, anti-human GITR (glucocorticoid-induced tumor necrosis factor receptor) monoclonal antibody
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria (Parts B \& C): * 18 years or older * Histologically confirmed unresectable Stage III or Stage IV malignant melanoma, or other solid tumor malignancies * Failed to respond to or relapsed following standard treatment, declined or was not eligible for standard treatment. * Expected...

Countries:United States
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