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A Phase 1 Multicenter, Dose Escalation Study of CBT-501 in Subjects With Select Advanced or Relapsed/Recurrent Solid Tumors
This is a Phase 1, multicenter, 2-part study with a Dose-Escalation Segment and Dose and Disease Expansion Cohort of CBT-501 injection, a humanized IgG4 monoclonal antibody, targeting the Programmed Death-1 (PD-1) membrane receptor on T lymphocytes and other cells of the immune system. Select advanced solid tumor malignancies will receive escalating doses of CBT-501.
Dose escalation will occur in three subject cohorts until a protocol defined dose limited toxicity (DLT) occurs, not due to disease progression or inter-current illness, and a tentative maximum tolerated dose (MTD) is determined.
At the tentative MTD or recommended Phase 2 dose (RP2D), at least two tumor types will be assessed to further evaluate toxicity and preliminary efficacy