To learn if ivonescimab can help to control previously treated, locally advanced or metastatic ACC or PPGL.
18 years of age or older. Because no dosing or adverse event data are currently available on the use of Ivonescimab in participants <18 years of age, children are excluded from this study.
Histological confirmation of ACC or PPGL. Histological confirmation of ACC based on either: i). Weiss Score of ≥ 3 in participants who had earlier surgical resection (Lin-Weiss-Bisceglia system will be used for oncocytic ACC) OR ii). biopsy results compatible with ACC in the context of clinical setting highly suggestive of ACC (adrenal mass > 4 cm invading surrounding organs or associated with distant metastases).
Locally advanced or metastatic disease not amenable to surgery
Participants must have measurable disease per RECIST v1.1. Participants must have a visceral or soft tissue metastasis measuring at least 10mm by the longest axis with CT scan or MRI. Nodal metastases must measure at least 15mm by short axis. Bone metastases require a soft tissue component with the longest axis being at least 10 mm to be considered measurable.
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.
Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for thyroid, adrenal or pituitary insufficiency) is permitted.
M.D. Anderson Cancer Center
Lead sponsor
Summit Therapeutics
Collaborator