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Study of SGR-1505 in Mature B-Cell Neoplasms

Primary Purpose

Mature B-Cell Neoplasm, Non Hodgkin Lymphoma, DLBCL

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
SGR-1505
Sponsored by
Schrödinger, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mature B-Cell Neoplasm focused on measuring MALT1, NF-kB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Life expectancy ≥ 12 weeks.

Exclusion Criteria:

  • For a subject with indolent NHL and CLL/SLL, the subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit) and has an indication for treatment.
  • 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.

Sites / Locations

  • Napa ResearchRecruiting
  • Regional Cancer Care AssociatesRecruiting
  • Gabrail Cancer & Research CenterRecruiting
  • OSU- The James Cancer HospitalRecruiting
  • Rhode Island HospitalRecruiting
  • Medical College of WisconsinRecruiting
  • Institute of Oncology, ARENSIA Exploratory MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dose Escalation

FE/DDI Cohort

Arm Description

Up to 11 dose levels will be evaluated. 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.

Participants will be dosed in a fed (high-fat, high-calorie meal) and fasted state to determine the effect of food on bioavailability of SGR-1505. Participants will be dosed with and without Posaconazole to determine the effect on the exposure of SGR-1505.

Outcomes

Primary Outcome Measures

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).
A DLT is an AE that requires treatment interruption.

Secondary Outcome Measures

SGR-1505 Maximal Plasma Concentration (Cmax)
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).
SGR-1505 Time to Maximal Plasma Concentration (tmax)
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)
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).
Effect of Food on the Cmax of SGR-1505
Plasma exposure parameters for SGR-1505 including, but not limited to, Cmax are evaluated following its administration with and without food.
Effect of Food on the tmax of SGR-1505
Plasma exposure parameters for SGR-1505 including, but not limited to, tmax, are evaluated following its administration with and without food.
Effect of Food on the AUC of SGR-1505
Plasma exposure parameters for SGR-1505 including, but not limited to, AUC are evaluated following its administration with and without food.
Effect of Posaconazole on the Cmax of SGR-1505
Plasma exposure parameters for SGR-1505 including, but not limited to, Cmax are evaluated following its administration alone and after co-administration with Posaconazole, a typical CYP3A4 inhibitor.
Effect of Posaconazole on the tmax of SGR-1505
Plasma exposure parameters for SGR-1505 including, but not limited to, tmax, are evaluated following its administration alone and after co-administration with Posaconazole, a typical CYP3A4 inhibitor.
Effect of Posaconazole on the AUC of SGR-1505
Plasma exposure parameters for SGR-1505 including, but not limited to, AUC are evaluated following its administration alone and after co-administration with Posaconazole, a typical CYP3A4 inhibitor.
Objective Response Rate (ORR)
Number of patients who have a complete response (CR) or partial response (PR) to treatment.
Duration of Response (DOR)
The time from response CR/PR until relapse or death from any cause.
Disease Control Rate
PR, CR, and SD for 2 post-baseline disease assessments at least 6 weeks apart.

Full Information

First Posted
August 19, 2022
Last Updated
September 10, 2023
Sponsor
Schrödinger, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05544019
Brief Title
Study of SGR-1505 in Mature B-Cell Neoplasms
Official Title
A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Schrödinger, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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) 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 sub-study will evaluate the effect of food and drug-drug interactions. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
MALT1, NF-kB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation
Arm Type
Experimental
Arm Description
Up to 11 dose levels will be evaluated. 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.
Arm Title
FE/DDI Cohort
Arm Type
Experimental
Arm Description
Participants will be dosed in a fed (high-fat, high-calorie meal) and fasted state to determine the effect of food on bioavailability of SGR-1505. Participants will be dosed with and without Posaconazole to determine the effect on the exposure of SGR-1505.
Intervention Type
Drug
Intervention Name(s)
SGR-1505
Intervention Description
SGR-1505 will be administered orally.
Primary Outcome Measure Information:
Title
Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation.
Time Frame
Throughout the study, up to 2 years.
Title
Nature and number of incidences of dose limiting toxicity (DLT).
Description
A DLT is an AE that requires treatment interruption.
Time Frame
The first 21 days.
Secondary Outcome Measure Information:
Title
SGR-1505 Maximal Plasma Concentration (Cmax)
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).
Time Frame
Through study completion, up to 2 years.
Title
SGR-1505 Time to Maximal Plasma Concentration (tmax)
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).
Time Frame
Through study completion, up to 2 years.
Title
SGR-1505 Area Under the Concentration Versus Time Curve (AUC)
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).
Time Frame
Through study completion, up to 2 years.
Title
Effect of Food on the Cmax of SGR-1505
Description
Plasma exposure parameters for SGR-1505 including, but not limited to, Cmax are evaluated following its administration with and without food.
Time Frame
Throughout the study, up to 2 years.
Title
Effect of Food on the tmax of SGR-1505
Description
Plasma exposure parameters for SGR-1505 including, but not limited to, tmax, are evaluated following its administration with and without food.
Time Frame
Throughout the study, up to 2 years.
Title
Effect of Food on the AUC of SGR-1505
Description
Plasma exposure parameters for SGR-1505 including, but not limited to, AUC are evaluated following its administration with and without food.
Time Frame
Throughout the study, up to 2 years.
Title
Effect of Posaconazole on the Cmax of SGR-1505
Description
Plasma exposure parameters for SGR-1505 including, but not limited to, Cmax are evaluated following its administration alone and after co-administration with Posaconazole, a typical CYP3A4 inhibitor.
Time Frame
Through study completion, up to 2 years.
Title
Effect of Posaconazole on the tmax of SGR-1505
Description
Plasma exposure parameters for SGR-1505 including, but not limited to, tmax, are evaluated following its administration alone and after co-administration with Posaconazole, a typical CYP3A4 inhibitor.
Time Frame
Through study completion, up to 2 years.
Title
Effect of Posaconazole on the AUC of SGR-1505
Description
Plasma exposure parameters for SGR-1505 including, but not limited to, AUC are evaluated following its administration alone and after co-administration with Posaconazole, a typical CYP3A4 inhibitor.
Time Frame
Through study completion, up to 2 years.
Title
Objective Response Rate (ORR)
Description
Number of patients who have a complete response (CR) or partial response (PR) to treatment.
Time Frame
Throughout the study, up to 2 years.
Title
Duration of Response (DOR)
Description
The time from response CR/PR until relapse or death from any cause.
Time Frame
Throughout the study, up to 2 years.
Title
Disease Control Rate
Description
PR, CR, and SD for 2 post-baseline disease assessments at least 6 weeks apart.
Time Frame
Throughout the study, up to 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Life expectancy ≥ 12 weeks. Exclusion Criteria: For a subject with indolent NHL and CLL/SLL, the subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit) and has an indication for treatment. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Physician
Phone
+15032991150
Email
sdgr-trials-group@schrodinger.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Weiss, M.D.
Organizational Affiliation
Schrodinger Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Napa Research
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
99064
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magda Hernandez
Phone
954-773-9890
Email
mhernandez@napa-trials.com
First Name & Middle Initial & Last Name & Degree
David Kahn, M.D.
Facility Name
Regional Cancer Care Associates
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Gonzales
Phone
732-530-8666
Email
melaniegonzalez@regionalcancercare.org
First Name & Middle Initial & Last Name & Degree
Iuliana Shapira, M.D.
Facility Name
Gabrail Cancer & Research Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carrie Smith, R.N.
Phone
330-492-3345
Ext
208
Email
CSmith@GabrailCancerCenter.com
First Name & Middle Initial & Last Name & Degree
Nashat Gabrail, M.D.
Facility Name
OSU- The James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
614-366-5643
First Name & Middle Initial & Last Name & Degree
Jennifer Woyach, MD
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Schumacher
Email
aschumacher@lifespan.org
First Name & Middle Initial & Last Name & Degree
Adam Olszewski, M.D.
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
414-805-8900
Email
_cccto@mcw.edu
Facility Name
Institute of Oncology, ARENSIA Exploratory Medicine
City
Chisinau
Country
Moldova, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vasile Musteata, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of SGR-1505 in Mature B-Cell Neoplasms

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