study to assess the safety, tolerability, and pharmacokinetics of AMP-224 in patients with advanced cancer

Inclusion Criteria

• Inclusion Criteria:
• - Must be able to provide informed consent
• - In Dose-Escalation: Must have solid tumor malignancy or cutaneous T-cell lymphoma that has relapsed and is refractory to standard therapy, or for which no standard therapy exists
• - In Expansion Phase: Must have melanoma or ovarian cancer that is histologically or cytologically confirmed
• - Ovarian cancer patients must have recurrent of persistent non-mucinous disease, and must not have received more than 2 prior chemotherapeutic regimens
• - Melanoma patients must have recurrent or persistent non-ocular AJCC Stage IIIC or IV disease that is surgically incurable and unresectable
• - Melanoma patients with documented BRAF mutation that is known to be responsive to BRAF inhibitors must have failed or be intolerant to such inhibitors
• - Must have measurable disease
• - Must be able to provide access to archival (Dose-Escalation Phase) and/or fresh tumor tissue (Dose-Escalation and Expansion Phases) at Screening prior to study entry
• - Must by at least 18 years old
• - Must have adequate organ function
• Exclusion Criteria:
• - Prior cancer therapies must have completed at least 14 days or 5 half-lives (whichever is longer) prior to first dose of AMP-224
• - Prior treatment with an anti-PD1 antibody therapy
• - Known antibody response against prior antibody therapy or fusion protein therapeutics
• - Major surgery within 4 weeks prior to first dose of AMP-224
• - Prior allogeneic or autologous bone marrow or organ transplantation
• - Known and/or a history or evidence of autoimmune disease except vitiligo, resolved childhood asthma and stable hypothyroidism
• - Received an immunomodulatory drug within 2 weeks of first dose of AMP-224
• - Active infections requiring antibiotics, physician monitoring, or recurrent fevers >100.4 degrees fahrenheit associated with a clinical diagnosis of active infection
• - Patients with cirrhosis
• - Clinically significant cardiac or electrocardiogram abnormalities
• - History or evidence of HIV
• - Active viral disease (except when the viral infection is associated with the malignancy)
• - Regular use of illicit drugs or a recent history of substance abuse
• - Pregnant or breastfeeding women