Study of SGR-1505 in Mature B-Cell Neoplasms
NCT05544019 · Phase 1 · Gilbert, Arizona, United States
- Condition
- Stomach Cancer
- Disease stage
- Stage I-IV
- Phase
- Phase 1
- Study type
- DRUG
- Intervention
- SGR-1505
- Age
- 18 Years to
- Gender
- All
- Sponsor
- Schrödinger, Inc.
- Research institution
- Schrödinger, Inc.
- Facility
- Banner Health - MD Anderson Cancer Center
- Research center
- Banner Health - MD Anderson Cancer Center
Summary
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.
Detailed description
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 the last 2 years. * Subject has a known allergy to SGR-1505 or excipients of SGR-1505. * Subject has symptomatic or active CNS involvement of disease. * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would place the participant at increased risk to the use of an investigational drug.
Primary outcomes
Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation.; Nature and number of incidences of dose limiting toxicity (DLT).
Secondary outcomes
SGR-1505 Maximal Plasma Concentration (Cmax); SGR-1505 Time to Maximal Plasma Concentration (tmax); SGR-1505 Area Under the Concentration Versus Time Curve (AUC)