Status:
COMPLETED
Trial of TRX518 (Anti-GITR mAb) in Stage III or IV Malignant Melanoma or Other Solid Tumors
Lead Sponsor:
Leap Therapeutics, Inc.
Collaborating Sponsors:
Cancer Research Institute, New York City
Conditions:
Unresectable Stage III or Stage IV Malignant Melanoma or Other Solid Tumor Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
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 re...
Eligibility Criteria
Inclusion
- 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 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.
- Exclusion Criteria (Parts B \& C):
- 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.
- 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).
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01239134
Start Date
October 1 2010
End Date
September 1 2018
Last Update
August 3 2025
Active Locations (1)
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1
Immunotherapeutics Core / Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065