Schrödinger, Inc.
The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or recommended dose (RD) of SGR-1505.
This is a study of SGR-1505, an oral inhibitor of MALT1, in subjects with relapsed/refractory (R/R) B-cell lymphomas to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or recommended dose (RD) of SGR-1505. Exploratory cohorts will evaluate additional PK, PD, preliminary anti-tumor activity, and safety to establish the SGR-1505 RD. A planned amendment will evaluate SGR-1505 in combination with other anti-cancer agents, such as BTK and BCL-2 inhibitors, in patients with specific B-cell malignancies.
Inclusion Criteria: * Subject must have a history of histologically or cytologically confirmed mature B-cell malignancy. * Subject must have measurable or detectable disease according to the applicable disease-specific classification system and meet criteria for initiation of treatment. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy ≥ 12 weeks. Exclusion Criteria: * The subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit). * Subject has previous invasive malignancy in…
SGR-1505 will be administered orally.