DynamiCure Biotechnology
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).
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…
Selected Inclusion Criteria: 1. Male or female patients ≥ 18 years of age. 2. Be willing and able to provide written informed consent for the study. 3. Patients in Phase 1a must have a histologically or cytologically documented, advanced (metastatic and/or unresectable) solid tumor that has progressed on or after standard therapy (relapsed/refractory patients; patients must have failed at least one prior line of therapy) or for whom there is no effective standard therapy based on the Investigator's judgment. Note: Patients with glioblastoma (GBM) or other central nervous system(CNS) tumor…
A monoclonal antibody that binds to CD93, DCSZ11 will be administered as a single intravenous (IV) infusion on Day 1 in each 21-day cycle.
Pembrolizumab injection
1b SOC Cohort 1: Doxorubicin combination in soft tissue sarcoma
1b SOC Cohort 2: Tebentafusp combination in uveal melanoma