Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
invoX Pharma Limited
Part 1a of the study will assess the safety and tolerability of SB 11285 as monotherapy in eligible patients with advanced solid tumors. Part 1b will assess the safety and tolerability of SB 11285 in combination with atezolizumab in patients with advanced solid tumors. RP2D decisions will be based on the totality of data, including DLTs, tolerability, PK, pharmacodynamics, and efficacy, as available. Part 2 will further evaluate the combination RP2D of SB 11285 and atezolizumab in selected tumor types. Both Parts 1a and 1b of the study will use a standard 3+3 dose-escalation design with the dose escalated in successive cohorts of 3 to 6 patients each within each cohort in an open-label fashion. In Part 1a Monotherapy Dose Escalation, patients who meet eligibility criteria will receive IV SB 11285 as monotherapy weekly on Days 1, 8, 15, and 22 of repeated 28-day cycles in escalating doses. Once Dose Level 2 of Part 1a monotherapy have been evaluated by the Safety Review Committee (SRC) and have been declared to be safe to dose escalate to Dose Level 3, Dose Level 1 of Part 1b Combination Dose Escalation (SB 11285 combination with atezolizumab) will be opened for enrollment. After determination of MTD and RP2D in SB 11285 plus atezolizumab combination the Part 2 with Expansion Cohorts will commence to further evaluate the RP2D.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
