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

Required: BRAF wild-type

BRAF wild type: progressed after receiving PD-1 containing therapy with or without an anti-CTLA-4

Required: PD-L1 (CD274) overexpression (TPS ≥ 1%)

PD-L1-positive (tumor proportion score [TPS] ≥ 1%) NSCLC

Required: EGFR activating mutation

NSCLC not harboring an activating EGFR mutation

Required: ALK rearrangement

NSCLC not harboring an...ALK rearrangement

Allowed: BRAF mutation

BRAF mutation: patients who refused BRAF+MEK inhibitor

Allowed: BRAF mutation

Patients with BRAF mutations must either be ineligible for or have refused a BRAF+MEK inhibitor

Must have received: anti-PD-1 therapy

progressed after receiving PD-1 containing therapy with or without an anti-CTLA-4

Must have received: anti-PD-1 therapy

progressed during or following treatment with an anti-PDx with or without platinum-based chemotherapy

Must have received: anti-CTLA-4 therapy

progressed after receiving PD-1 containing therapy with or without an anti-CTLA-4

Must have received: anti-LAG-3 therapy

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)

Must have received: BRAF inhibitor

patients who refused BRAF+MEK inhibitor

Must have received: MEK inhibitor

patients who refused BRAF+MEK inhibitor

Cannot have received: IL-2 therapy

Exception: Patients who have experienced serious adverse events during prior IL-2 therapy (including but not limited to bowel perforation, gastrointestinal bleeding, arrythmias, myocardial infarction, repetitive seizures)

Patients who have experienced serious adverse events during prior IL-2 therapy (including but not limited to bowel perforation, gastrointestinal bleeding, arrythmias, myocardial infarction, repetitive seizures)