Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

Selected Inclusion Criteria: * Patients must have measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI * Part 2 includes but is not limited to: * Cutaneous melanoma that is either locally unresectable or metastatic: * BRAF wild type: progressed after receiving PD-1 containing therapy with or without an anti-CTLA-4 * BRAF mutation: patients who refused BRAF+MEK inhibitor * Must have objective progression after receiving at least two cycles of prior doublet therapy (anti-PD-1/anti-CTLA-4 or anti-PD-1/anti-LAG-3) * Radiographic progression ≥ 4 weeks prior to the first dose of study drug to rule out late response to most recent therapy. The requirement for documented radiologic progression may be waived after review by Medical Monitor (e.g., in the case of progression beyond 12 weeks after starting a doublet) * LDH ≤ 2.5 x ULN * NSCLC: Unresectable locally advanced or metastatic PD-L1-positive (tumor proportion score \[TPS\] ≥ 1%) NSCLC not harboring an activating EGFR mutation or ALK rearrangement and has progressed during or following treatment with an anti-PDx with or without platinum-based chemotherapy * Part 3: NSCLC as described above * Part 4: cutaneous melanoma * Unresectable locally advanced or metastatic cutaneous melanoma that has progressed during or following treatment with an anti-PDx (unless ineligible for anti-PDx therapy) * Patients with BRAF mutations must either be ineligible for or have refused a BRAF+MEK inhibitor …