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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

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

TRX518 · 1 trial · 1 indication

Phase 1 1
NCT01239134Trial of TRX518 (Anti-GITR mAb) in Stage III or IV Malignant Melanoma or Other Solid TumorsUnresectable Stage III or Stage IV Malignant Melanoma or Other Solid Tumor Malignancies
COMPLETED10 Analytics
PHASE1COMPLETED
Trial of TRX518 (Anti-GITR mAb) in Stage III or IV Malignant Melanoma or Other Solid Tumors
Unresectable Stage III or Stage IV Malignant Melanoma or Other Solid Tumor Malignancies
NCT0123913410
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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 to 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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Frequently asked questions about TRX518

What is TRX518 used for?

TRX518 is an investigational monoclonal antibody being studied for the treatment of unresectable Stage III or Stage IV malignant melanoma and other solid tumor malignancies, as well as solid tumors. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does TRX518 target?

TRX518 is a monoclonal antibody designed to target GITR, a protein involved in immune regulation. By binding to GITR, TRX518 aims to modulate the immune system's response against tumor cells, potentially enhancing anti-tumor activity in patients with certain cancers.

Who is developing TRX518?

TRX518 is being developed by Cypherpunk Technologies Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of TRX518 in patients with advanced melanoma and other solid tumors.

What phase is TRX518 in?

TRX518 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. Clinical trials are ongoing to assess its safety, tolerability, and potential efficacy in treating certain types of cancer.

What clinical trials is TRX518 in?

TRX518 has been studied in two completed Phase 1 clinical trials. The first trial, NCT01239134, evaluated TRX518 in patients with unresectable Stage III or Stage IV malignant melanoma or other solid tumors. The second trial, NCT02628574, assessed TRX518 as monotherapy and in combination with gemcitabine, pembrolizumab, or nivolumab in patients with solid tumors.

Is TRX518 the same as anti-GITR mAb?

TRX518 is also known as anti-GITR mAb, as it is a monoclonal antibody that targets GITR. In clinical trial records, it is sometimes referred to by this descriptive name. Both names refer to the same investigational drug being developed by Cypherpunk Technologies Inc.