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

Inclusion Criteria

• 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).