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.
Brief Title
Study of SGR-1505 in Mature B-Cell Neoplasms
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
+1 (503)-922-0158
Central Contact Email
sdgr-trials-group@schrodinger.com
Completion Date
Completion Date Type
Estimated
Conditions
Mature B-Cell Neoplasm
Non Hodgkin Lymphoma
DLBCL
Waldenstrom Macroglobulinemia
MALT Lymphoma
Follicular Lymphoma
Pediatric-Type Follicular Lymphoma
IRF4 Gene Rearrangement
EBV-Positive DLBCL, Nos
Burkitt Lymphoma
Plasmablastic Lymphoma
High-grade B-cell Lymphoma
Primary Cutaneous Follicle Center Lymphoma
Primary Effusion Lymphoma
Mantle Cell Lymphoma
DLBCL Germinal Center B-Cell Type
Primary Mediastinal Large B Cell Lymphoma
T-Cell/Histiocyte Rich Lymphoma
ALK-Positive Large B-Cell Lymphoma
Primary Cutaneous Diffuse Large B-Cell Lymphoma
Splenic Marginal Zone Lymphoma
Chronic Lymphocytic Leukemia
Nodal Marginal Zone Lymphoma
HHV8-Positive DLBCL, Nos
Lymphoplasmacytic Lymphoma
Duodenal-Type Follicular Lymphoma
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.
* 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.
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
MALT1
NF-kB
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05544019
Org Class
Industry
Org Full Name
Schrödinger, Inc.
Org Study Id
SGR-1505-101
Overall Status
Recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies
Primary Outcomes
Outcome Measure
Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation.
Outcome Time Frame
Throughout the study, up to 2 years.
Outcome Description
A DLT is an AE that requires treatment interruption.
Outcome Measure
Nature and number of incidences of dose limiting toxicity (DLT).
Outcome Time Frame
The first 21 days.
Secondary Outcomes
Outcome Description
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).
Outcome Time Frame
Through study completion, up to 2 years.
Outcome Measure
SGR-1505 Maximal Plasma Concentration (Cmax)
Outcome Description
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).
Outcome Time Frame
Through study completion, up to 2 years.
Outcome Measure
SGR-1505 Time to Maximal Plasma Concentration (tmax)
Outcome Description
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).
Outcome Time Frame
Through study completion, up to 2 years.
Outcome Measure
SGR-1505 Area Under the Concentration Versus Time Curve (AUC)
Outcome Description
Number of patients who have an objective response per response criteria other than stable disease (SD) or progressive disease (PD) to treatment.
Outcome Time Frame
Throughout the study, up to 2 years.
Outcome Measure
Objective Response Rate (ORR)
Outcome Description
The time from response CR/PR until relapse or death from any cause.
Outcome Time Frame
Throughout the study, up to 2 years.
Outcome Measure
Duration of Response (DOR)
Outcome Description
PR, CR, and SD for 2 post-baseline disease assessments at least 6 weeks apart.
Outcome Time Frame
Throughout the study, up to 2 years.
Outcome Measure
Disease Control Rate
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Noah Kornblum
Investigator Email
nkornblu@montefiore.org
Investigator Phone
718-920-4826