Non Hodgkin Lymphoma Clinical Trial
Study of SGR-1505 in Mature B-Cell Neoplasms
Summary
The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of SGR-1505.
Full 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.
Eligibility Criteria
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.
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There are 14 Locations for this study
Newark Delaware, 19713, United States More Info
Pompano Beach Florida, 99064, United States More Info
Principal Investigator
Hackensack New Jersey, 07601, United States More Info
Principal Investigator
Bronx New York, 10467, United States
Durham North Carolina, 27710, United States
Canton Ohio, 44718, United States More Info
Principal Investigator
Columbus Ohio, 43210, United States More Info
Principal Investigator
Portland Oregon, 97329, United States More Info
Providence Rhode Island, 02903, United States More Info
Principal Investigator
Dallas Texas, 75390, United States
Seattle Washington, 98109, United States More Info
Principal Investigator
Chisinau , , Moldova, Republic of More Info
Principal Investigator
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