Study of SGR-1505 in Mature B-Cell Neoplasms
- Conditions
- MALT LymphomaBurkitt LymphomaPrimary Effusion LymphomaALK-Positive Large B-Cell LymphomaMature B-Cell NeoplasmNon Hodgkin LymphomaDLBCLFollicular LymphomaIRF4 Gene RearrangementEBV-Positive DLBCL, Nos
- Interventions
- Registration Number
- NCT05544019
- Lead Sponsor
- Schrödinger, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 52
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation SGR-1505 Up to 9 dose levels in total will be evaluated across two dosing schedules. Eligible patients will be assigned to a dose level cohort according to an accelerated titration design that will transition to a traditional 3+3 dose escalation.
- Primary Outcome Measures
Name Time Method Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation. Throughout the study, up to 2 years. Nature and number of incidences of dose limiting toxicity (DLT). The first 21 days. A DLT is an AE that requires treatment interruption.
- Secondary Outcome Measures
Name Time Method SGR-1505 Time to Maximal Plasma Concentration (tmax) Through study completion, up to 2 years. Concentrations of SGR-1505 in plasma are measured at various timepoints following its administration to calculate typical exposure/PK parameters, including, but not limited to, the time to maximal plasma concentration (tmax).
SGR-1505 Area Under the Concentration Versus Time Curve (AUC) Through study completion, up to 2 years. Concentrations of SGR-1505 in plasma are measured at various timepoints following its administration to calculate typical exposure/PK parameters, including, but not limited to, the area under the concentration versus time curve (AUC).
Objective Response Rate (ORR) Throughout the study, up to 2 years. Number of patients who have an objective response per response criteria other than stable disease (SD) or progressive disease (PD) to treatment.
SGR-1505 Maximal Plasma Concentration (Cmax) Through study completion, up to 2 years. Concentrations of SGR-1505 in plasma are measured at various timepoints following its administration to calculate typical exposure/PK parameters, including, but not limited to, the maximal plasma concentration (Cmax).
Duration of Response (DOR) Throughout the study, up to 2 years. The time from response CR/PR until relapse or death from any cause.
Disease Control Rate Throughout the study, up to 2 years. PR, CR, and SD for 2 post-baseline disease assessments at least 6 weeks apart.
Trial Locations
- Locations (17)
Duke University
🇺🇸Durham, North Carolina, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Napa Research
🇺🇸Pompano Beach, Florida, United States
Christiana Care Hospital - Helen F Graham Cancer Center
🇺🇸Newark, Delaware, United States
Weill Cornell
🇺🇸New York, New York, United States
Oregon Health and Science University - Knight Cancer Institute
🇺🇸Portland, Oregon, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Roswell Park Comprehensive Cancer Center
🇺🇸Buffalo, New York, United States
Gabrail Cancer & Research Center
🇺🇸Canton, Ohio, United States
The Ohio State University - The James Cancer Hospital
🇺🇸Columbus, Ohio, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
Regional Cancer Care Associates
🇺🇸Hackensack, New Jersey, United States
Banner Health - MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Institute of Oncology, ARENSIA Exploratory Medicine
🇲🇩Chisinau, Moldova, Republic of
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States