Patients and treatment
aggressive tumors, DLBCL
SOLID TUMORS
Patients were enrolled at 11 study sites in France, Italy, Japan, and Spain. Patient enrollment in part A took place between July 31, 2017 and November 12, 2018, with a total of 69 patients enrolled and treated, of whom 67 had advanced or unresectable solid tumors and two had R/R DLBCL. Patient enrollment in part B began on June 18, 2019, and was ongoing at the time of the data cutoff; the last patient enrolled at the time of the data cutoff was enrolled on January 11, 2021. In total, 23 patients with R/R DLBCL were enrolled and treated in part B, of whom 19 received trotabresib 45 mg/day 4 days on/24 days off and four received an alternate RP2D dose and schedule of trotabresib 30 mg/day 3 days on/11 days off. The alternate RP2D was investigated further because it had comparable tolerability to 45 mg/day 4 days on/24 days off, delivered the same cumulative dose over a 28-day treatment cycle, and was potentially more suitable for the treatment of patients with aggressive tumors such as R/R DLBCL, due to more constant exposure and target engagement. Patient enrollment in Part C took place between October 21, 2019 and July 27, 2020, with a total of 41 patients with advanced solid tumors enrolled to evaluate the effects of food on the PK and safety profile of trotabresib 45 mg/day 4 days on/24 days off.Details of patient disposition are shown in Fig. 