A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0111 in Patients With Solid Tumors

Required: HER2 (ERBB2) negative (0 to 1+)

Required: ESR1 negative (<1% positive tumor cells)

Required: PR (PGR) negative (<1% positive tumor cells)

Cannot have received: systemic anti-cancer therapy

Use of any of the following ≤ 3 weeks prior to CIVO injection: a. Systemic anti-cancer therapy (e.g., cytotoxic chemotherapy, targeted agents, or checkpoint inhibitor immunotherapy, etc.)

Cannot have received: immunosuppressive drugs (calcineurin inhibitors)

Immunosuppressive drugs (e.g., calcineurin inhibitors)

Cannot have received: biological response modifiers for autoimmune disease

Biological response modifiers for autoimmune disease

Cannot have received: systemic glucocorticoids (oral or parenteral corticosteroids at a dose ≥ 20 mg/day prednisone, or equivalent)

Exception: physiologic replacement dosing (≤ 3 mg/m2/d prednisone or equivalent), low-dose corticosteroids for dye allergies prior to staging scans or use in anti-emetic prophylaxis for patients undergoing chemotherapy, or topical steroids, are allowed

Systemic glucocorticoids: oral or parenteral corticosteroids at a dose ≥ 20 mg/day prednisone, or equivalent

Cannot have received: hematopoietic growth factors

Hematopoietic growth factors

Cannot have received: chemotherapy

Chemotherapy

Cannot have received: local radiotherapy

Local radiotherapy of the target lesion planned for CIVO injection and surgical resection