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NCT01239134 · ClinicalTrials.gov registry record · Phase 1
Trial of TRX518 (Anti-GITR mAb) in Stage III or IV Malignant Melanoma or Other Solid Tumors
A Phase 1 study, sponsored by Leap Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01239134: Completed Phase 1 study, sponsored by Leap Therapeutics.
NCT01239134 is a Phase 1 study that has completed, run by Leap Therapeutics. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01239134, a Phase 1 study, has completed, sponsored by Leap Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
TRX518-001 is an open label, non-randomized single group assignment, Phase 1 single dose escalation study in adults with biopsy proven unresectable Stage III or Stage IV melanoma or other solid tumor malignancies. Part A: The study objectives are to determine the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of TRX518 and to define the maximum tolerated dose at which there are tolerable side effects and/or maximum PK/PD parameter changes. Subjects will be assigned to a cohort in the order screening is completed. Dose will depend upon the cohort in which a subject is enrolled and cohorts will be dosed consecutively by ascending dose. Part A has been completed. Part B: A Dose-Escalation Study of Multi-dose TRX518 Monotherapy with objectives including characterization of the safety, tolerability, and pharmacokinetics, as well as, evaluate for evidence of anti-tumor activity and assess TRX518 immunogenicity. Part C: An Expansion Cohort of Multi-dose TRX518 Monotherapy at the Maximum Tolerated Dose
Primary Outcome
Any adverse change in health or side effect from the initiation of the study drug dose through completion or premature withdrawal
Interventions
- BIOLOGICAL TRX518
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2010-10 |
| Est. Completion | 2018-09 |
| Phase | Phase 1 |
What the finished NCT01239134 record still lists
NCT01239134 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which TRX518 is the first listed.
NCT01239134 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01239134 about?
NCT01239134 is a clinical study titled "Trial of TRX518 (Anti-GITR mAb) in Stage III or IV Malignant Melanoma or Other Solid Tumors". TRX518-001 is an open label, non-randomized single group assignment, Phase 1 single dose escalation study in adults with biopsy proven unresectable Stage III or Stage IV melanoma or other solid tumor malignancies. Part A: The study objectives are to determine the safety, tolerability, pharmacokinet...
What is the current status of trial NCT01239134?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2010-10. Estimated completion is 2018-09.
What interventions are being tested in trial NCT01239134?
The interventions under investigation include: TRX518 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01239134?
This trial is sponsored by Leap Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01239134's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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