Safety and Tolerability of SYNB1891 Injection Alone or in Combination With Atezolizumab in Adult Subjects

Summary

Participation Requirements

Description

This phase 1, open-label, multicenter, 2-arm study of SYNB1891 in subjects diagnosed with advanced/metastatic solid tumors and lymphoma will evaluate safety and tolerability of escalating doses of intratumoral injections of SYNB1891 to determine single-agent maximum tolerated dose (MTD) as monothera...

This phase 1, open-label, multicenter, 2-arm study of SYNB1891 in subjects diagnosed with advanced/metastatic solid tumors and lymphoma will evaluate safety and tolerability of escalating doses of intratumoral injections of SYNB1891 to determine single-agent maximum tolerated dose (MTD) as monotherapy and the recommended Phase 2 dose (RP2D) in combination with atezolizumab. The incidence of dose-limiting toxicities (DLTs), kinetics and pharmacodynamics will be evaluated in 2 arms: Arm 1 comprises escalating doses of intratumoral injections of SYNB1891 monotherapy for up to four 21-day cycles with up to 24 months following initial treatment for those determined not to have progressive disease at the end of Cycle 4. Up to 7 dose cohorts will be evaluated to identify MTD within the dose range studied. Up to 35 patients may be enrolled in this arm of the study. Following attainment of MTD, Arm 2 will be initiated. Arm 2 comprises escalating doses of intratumoral injections of SYNB1891 for up to four 21-day cycles with up to 24 months following initial treatment for those determined not to have progressive disease at the end of Cycle 4. In addition, atezolizumab will be administered as an intravenous (IV) infusion in accordance with its recommended dose and schedule during each of the planned 4 cycles with up to 24 months following initial treatment for those determined not to have progressive disease at the end of Cycle 4. Up to 3 dose cohorts will be evaluated to identify RP2D in combination with atezolizumab. Up to 12 patients may be enrolled in Arm 2. An additional 20 subjects may be enrolled in an extension combination. Safety will be monitored continuously by documentation of adverse events (AEs), serious adverse events (SAEs), clinical laboratory measurements, vital signs and physical examinations. DLTs will be evaluated at the end of Cycle 1 in both Arms 1 and 2.

Tracking Information