STOMP OUT: A Phase 2 Study To Evaluate The Effects Of Ivonescimab In Patients With Unresectable/Metastatic Adrenocortical Carcinoma (ACC) Or Unresectable Pheochromocytoma/Paraganglioma (PPGL)

Exclusion criteria

• . Received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 4 weeks of the start of the previous cycle or had received previous targeted therapy including small molecular tyrosine kinase inhibitors such as belzutifan, cabozantinib or lenvatinib within 2 weeks before the first dose of study treatment.
• . Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
• . Major surgical procedures or serious trauma within 4 weeks prior to enrollment or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to enrollment.
• . Active autoimmune or lung disease requiring systemic therapy (e.g., with disease modifying drugs, prednisone \>10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to first dose of study treatment however the following will be allowed:
• . Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for thyroid, adrenal or pituitary insufficiency) is permitted.
• . Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted
• . Psoriasis requiring topical treatment only, vitiligo, history of Hashimoto's thyroiditis, Grave's disease, history of radiographic diagnosis of rheumatoid arthritis without active therapy is allowed.