Trial · NCT01239134
Trial of TRX518 (Anti-GITR mAb) in Stage III or IV Malignant Melanoma or Other Solid Tumors
NCT01239134, Phase 1, Completed, Leap Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Trial of TRX518 (Anti-GITR mAb) in Stage III or IV Malignant Melanoma or Other Solid Tumors. Trials, record NCT01239134. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01239134
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of TRX518 (Anti-GITR mAb) in Stage III or IV Malignant Melanoma or Other Solid Tumors
- NCT number
- NCT01239134
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 10 participants, actual
- Lead sponsor
- Leap Therapeutics, Inc.
- Conditions
- Unresectable Stage III or Stage IV Malignant Melanoma or Other Solid Tumor Malignancies
- Interventions
- TRX518
- First posted
- 2010-11-11
- Last updated
- 2025-08-03
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 |
| Primary | 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 |
| Primary | 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 |
| Primary | 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 |
| Primary | 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) | |
| Primary | 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 | 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 | |
| Secondary | Part A: Assess TRX518 immunogenicity | At baseline and at various timepoints up to 18 weeks post dose | |
| Secondary | 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 | |
| Secondary | Parts B & C: TRX518 peak concentration (Cmax) | At each study visit from baseline up to end of treatment visit | 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 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01239134
GET https://conductscience.org/api/trials/v1/NCT01239134/registered