Perlmutter Cancer Center

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Solid Tumors
  Melanoma
• Age: Between 18 Year(s) - 100 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  In order to participate the following conditions must be met:

  1. In the dose-expansion cohorts, subjects will have one of the following histologically or cytologically confirmed metastatic or unresectable solid malignancy within one of the tumor types listed below: • Cutaneous melanoma, non small cell lung cancer (NSCLC), Colorectal cancer (CRC), pancreatic cancer, mesothelioma
  2. Subjects must have disease that is relapsed, refractory, or intolerant to standard of care therapies and in the judgement of the investigator must not have other therapeutic options known to provide clinical benefit. Key eligibility criteria include measurable disease per RECIST v1.1 at baseline, an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, and adequate renal, hepatic, and hematologic function.
  3. Subjects with cutaneous melanoma must have been previously treated with an anti-programmed death-1 (anti-PD-1) or an anti-programmed death ligand-1 (anti-PD-L1) agent administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. Subjects with cutaneous melanoma with a targetable BRAF mutation must have been treated with, been intolerant of, or declined treatment with BRAF/MEK targeted therapy prior to study entry.

  
  

You may not be eligible for this study if the following are true:

• You will not be able to participate in the study if you have had:

  1. History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.
  2. Known active central nervous system metastases or leptomeningeal disease.
  3. Any active viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug, unless deemed not clinically significant by the investigator (eg, onychomycosis).