AN0025 and Pembrolizumab Combination in Advanced Solid Tumors

Inclusion criteria

• ✓. Age ≥18 years at the time of informed consent.
• ✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• ✓. Life expectancy ≥3 months.
• ✓. Diagnosed with histologically confirmed locally advanced and nonresectable, or metastatic disease.
• ✓. Have progressed on treatment with an anti-PD-1/PD-L1monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies (cohort A, B or C) and have failed available standard of care treatment or deemed inappropriate candidates for additional standard treatments by the investigator. PD-1 treatment progression is defined by meeting all of the following criteria:
• ✓. Has received at least 2 doses of an approved anti-PD-1/PD-L1 mAb.
• ✓. Has demonstrated disease progression after PD-1/PD-L1 as defined by RECIST v1.1. The initial evidence of disease progression (PD) is to be confirmed by a second assessment no less than four weeks from the date of the first documented PD, in the absence of rapid clinical progression. i,ii
• ✓. Progressive disease has been documented within 12 weeks from the last dose of anti-PD-1/L1 mAb.

Exclusion criteria