RecruitingPhase 1NCT05544019
Study of SGR-1505 in Mature B-Cell Neoplasms
A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies
Sponsor
Schrödinger, Inc.
Enrollment
98 participants
Start Date
Apr 10, 2023
Study Type
INTERVENTIONAL
Conditions
High-grade B-cell LymphomaChronic Lymphocytic LeukemiaNon-Hodgkin LymphomaMantle Cell LymphomaFollicular LymphomaPlasmablastic LymphomaBurkitt LymphomaSplenic Marginal Zone LymphomaNodal Marginal Zone LymphomaMature B-Cell NeoplasmWaldenstrom MacroglobulinemiaLymphoplasmacytic LymphomaPrimary Mediastinal Large B Cell LymphomaDLBCLDLBCL Germinal Center B-Cell TypeALK-Positive Large B-Cell LymphomaMALT LymphomaPediatric-Type Follicular LymphomaIRF4 Gene RearrangementEBV-Positive DLBCL, NosPrimary Cutaneous Follicle Center LymphomaPrimary Effusion LymphomaT-Cell/Histiocyte Rich LymphomaPrimary Cutaneous Diffuse Large B-Cell LymphomaHHV8-Positive DLBCL, NosDuodenal-Type Follicular Lymphoma
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria5
- 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.
Interventions
DRUGSGR-1505
SGR-1505 will be administered orally.
Locations(36)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05544019
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