A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors
DynamiCure Biotechnology
Summary
This is a multicenter, open-label, Phase 1 study to assess the effects of DCSZ11 as a monotherapy and in combination in patients with advanced or metastatic solid tumors. The study consists of an Escalation Phase (Phase 1a) and a Dose Expansion/Optimization Phase (Phase 1b).
Description
DCSZ11 will be administered as monotherapy and in combination with pembrolizumab in patients with advanced-stage or metastatic solid tumors. The Escalation Phase will be followed by a Dose Expansion/Optimization Phase (Phase 1b) to further characterize safety, PK, pharmacodynamics, and evidence of antitumor activity of DCSZ11 in combination with pembrolizumab in select relapsed/refractory (R/R) solid tumors and, if desired, optimize the DCSZ11 dose. Phase 1a - Dose Escalation Phase 1a is a dose escalation study of DCSZ11 as monotherapy in Part 1 and in combination with pembrolizumab in Part 2…