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Unresectable Stage III or Stage IV Malignant Melanoma or Other Solid Tumor MalignanciesPhase 1TRX518-001NCT01239134

Trial of TRX518 (Anti-GITR mAb) in Stage III or IV Malignant Melanoma or Other Solid Tumors

A Phase 1 study testing TRX518 in people with Unresectable Stage III or Stage IV Malignant Melanoma or Other Solid Tumor Malignancies, run by Leap Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TRX518
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Oct 2010to Sep 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 survival of at least 12 weeks.
  • Eastern Cooperative Oncology Group performance status score of 0 or 1 is required.
  • Evidence of adequate organ function by standard laboratory tests.

Who cannot join

  • Evidence of progression of central nervous system (CNS) metastases or symptomatic CNS metastases within 35 days prior to dosing.
  • Ocular melanoma which has not metastasized or presence of a non-solid tumor.
  • A history of any major surgery within 4 weeks prior to dosing.
  • Any history of antitumor therapy completed within 28 days prior to dosing.
  • Subjects with active autoimmune disease or history of known or suspected autoimmune disease, with the exception of subjects with isolated vitiligo, resolved childhood asthma/atopy, psoriasis not requiring systemic treatment and controlled thyroid disorders.
  • Clinically significant heart disease, defined as NYHA Class III or IV.
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  • Any significant systemic infection requiring IV antibiotics.
  • Known to be human immunodeficiency virus (HIV) positive, have hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCAb) unless HCV RNA undetected/negative.
  • Treatment with any other anti-human GITR monoclonal antibody (mAb) or immunomodulatory therapy 42 days prior to dosing (30 days for Interleukin-2 \& Interferon-α, 7 days for Topical Imiquimod).
  • Adverse events from prior anti-cancer therapy that have not resolved to grade ≤1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy.
  • Use of any investigational drugs within 30 days prior to dosing.
  • Any condition that requires or is likely to require treatment with pharmacologic doses of systemic corticosteroids. Subjects are permitted to receive physiologic replacement of corticosteroid therapy (≤ 10 mg prednisone daily).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Immunotherapeutics Core / Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: Part A: A First-in-Human Single Ascending Dose Study of TRX518 in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma or Other Solid Tumor Malignancies Part B: A Dose-Escalation Study of Multi-dose TRX518 Monotherapy Part C: An Expansion Cohort of Multi-dose TRX518 Monotherapy at the Maximum Tolerated Dose

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.

Read more

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

Read the detailed description

The following visits are required:

Part A:

  • Screening visit: 1 to 2 appointments will be conducted to determine eligibility. All or most requirements can be determined from the patient's medical records.
  • Baseline visit: within 7 days of the planned study dosing day a baseline physical exam, blood tests and electrocardiogram will be obtained.
  • Dosing visit: 1 outpatient visit where TRX518 will be given IV over 1 hour followed by 4 hours of observation and some repeat blood tests.
  • Follow up visits: 5 outpatient visits following dosing at 1, 8 and 15 days and 3, 6, 12, and 18 weeks post dosing
  • Long term follow-up: 4 brief assessments by medical record review and/or telephone contact at 6, 12, 18, and 24 months post dosing.
  • The core study duration is 18 weeks. The follow-up study duration is 24 months.

Parts B \& C:

  • Screening/Baseline visit: 1 appointment will be conducted to perform testing and evaluations for eligibility within 28 days of the first dosing day.
  • Dosing Visits: Each subject will receive IV doses of TRX518 once every other week (e.g., D1 and D15) in 28-day cycles
  • Follow up visits: When a patient stops treatment, they will enter the Follow-up Period and have an End of Treatment study visit approximately 30 days after the last dose of study drug. Subsequently, patients will have long-term follow-up approximately every 12 weeks until death or lost to follow up.
Being tested
TRX518
Keywords
Malignant melanoma, Metastatic, Unresectable, Stage III or Stage IV, Solid tumor
Medical subject headings
Melanoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRX518Biological

    Humanized, Fc disabled, anti-human GITR (glucocorticoid-induced tumor necrosis factor receptor) monoclonal antibody

Study groups in NCT01239134
Study groupRoleWhat they receive
TRX518ExperimentalNot described
Receives: Biological: TRX518

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Adverse Events

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

    Measured: through 30 days post last dose

  2. Part A: TRX518 peak concentration (Cmax)

    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

    Measured: various timepoints through 1 week post dose

  3. Part A: Time to peak concentration (Tmax)

    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

    Measured: various timepoints through 1 week post dose

  4. Part A: Area under the curve (AUC)

    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

    Measured: various timepoints through 1 week post dose

  5. Part A: Define a maximum single dose at which there are tolerable side effects and/or maximum PK/PcD parameter changes

    Measured: End of Cycle 1 (Day 28)

  6. Parts B and C: Adverse Events

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

    Measured: through 30 days post dose

Secondary outcomes (9)

  1. Part A: Evaluate the effect of TRX518 on lymphoid cell subset number and function

    Measured: At baseline and at various timepoints up to 6 weeks post dose

  2. Part A: Assess TRX518 immunogenicity

    Measured: At baseline and at various timepoints up to 18 weeks post dose

  3. Part A: Evaluate the effect of TRX518 on long-term safety measuring vital signs, tumor status, adverse events

    Measured: At Months 6, 12, 18 and 24

  4. Parts B & C: TRX518 peak concentration (Cmax)

    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

    Measured: At each study visit from baseline up to end of treatment visit

  5. Parts B & C: Time to peak concentration (Tmax)

    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

    Measured: At each study visit from baseline up to end of treatment visit

  6. Parts B & C: Area under the curve (AUC)

    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

    Measured: At each study visit from baseline up to end of treatment visit

  7. Parts B & C: Evaluate multi-dose TRX18 monotherapy for any evidence of antitumor activity (objective response rate, [ORR] progression free survival [PFS], duration of response and overall survival [OS]; RECIST v1.1 will be utilized

    objective response rate [ORR], progression free survival [PFS], duration of response [DoR] and overall survival [OS]); RECIST v1.1 criteria will be utilized

    Measured: Every 8 weeks while on study treatment and every 12 weeks for survival until death or lost to follow up.

  8. Parts B & C: Evaluate the effect of multi-dose TRX518 monotherapy on lymphoid cell subset number and function

    Measured: At baseline and at various timepoints up to end of treatment visit

  9. Parts B & C: Assess TRX518 immunogenicity

    Measured: At baseline and at various timepoints up to end of treatment visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionSep 2018
  4. Study completionSep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01239134
Sponsor's protocol ID
TRX518-001
Acronym
TRX518-001
Status last verified
Jul 2025
First submitted
9 Nov 2010
Last updated
3 Aug 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TRX518 in people with Unresectable Stage III or Stage IV Malignant Melanoma or Other Solid Tumor Malignancies, run by Leap Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Adverse Events (time frame: through 30 days post last dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01239134.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.

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