This is a first-in-human, phase 1, open-label, dose-escalation study of STI-6643 administered by intravenous infusion in subjects with a relapsed/refractory advanced solid tumor.
A Phase 1, Open-Label, Dose-Escalation Study of the Safety and Efficacy of STI-6643, an Anti-CD47 Human Monoclonal Antibody, in Subjects With Advanced Solid Tumors
This is a first-in-human, phase 1, open-label, dose-escalation study of STI-6643 administered by intravenous infusion in subjects with a relapsed/refractory advanced solid tumor. The study will determine an MTD and RP2D using a conventional 3+3 study design with dose limiting toxicity evaluated over the initial 28 days of STI-6643 administration. The schedule of STI-6643 administration will be weekly for the initial 4 weeks of a 5-week cycle and then every 2 weeks thereafter (i.e., starting with Cycle 2) of a 4-week cycle. Subjects will continue to receive STI-6643 in the absence of progression or unacceptable toxicity. Subjects with minimal toxicity will have the option of decreasing the frequency of their clinic visits during later cycles.
