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.

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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) 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.

View Eligibility Criteria

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

52

Study ID:

NCT05544019

Recruitment Status:

Recruiting

Sponsor:

Schrödinger, Inc.

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There are 14 Locations for this study

See Locations Near You

Banner Health - MD Anderson Cancer Center
Gilbert Arizona, 85234, United States More Info
Bryan Crabtree
Contact
480-256-5411
[email protected]
Christiana Care Hospital - Helen F Graham Cancer Center
Newark Delaware, 19713, United States More Info
Denise Demaio, BSN, RN
Contact
302-623-4639
[email protected]
Napa Research
Pompano Beach Florida, 99064, United States More Info
Magda Hernandez
Contact
954-773-9890
[email protected]
David Kahn, M.D.
Principal Investigator
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States More Info
Regional Cancer Care Associates
Hackensack New Jersey, 07601, United States More Info
Melanie Gonzales
Contact
732-530-8666
[email protected]
Iuliana Shapira, M.D.
Principal Investigator
Montefiore Medical Center
Bronx New York, 10467, United States
Duke University
Durham North Carolina, 27710, United States
Gabrail Cancer & Research Center
Canton Ohio, 44718, United States More Info
Carrie Smith, R.N.
Contact
330-492-3345
[email protected]
Nashat Gabrail, M.D.
Principal Investigator
The Ohio State University - The James Cancer Hospital
Columbus Ohio, 43210, United States More Info
Contact
614-366-5643
Jennifer Woyach, MD
Principal Investigator
Oregon Health and Science University - Knight Cancer Institute
Portland Oregon, 97329, United States More Info
Knight Clinical Trials
Contact
503-494-1080
[email protected]
Rhode Island Hospital
Providence Rhode Island, 02903, United States More Info
Andrew Schumacher
Contact
[email protected]
Adam Olszewski, M.D.
Principal Investigator
University of Texas Southwestern
Dallas Texas, 75390, United States
Fred Hutchinson Cancer Center
Seattle Washington, 98109, United States More Info
Ajay Gopal, MD
Principal Investigator
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Institute of Oncology, ARENSIA Exploratory Medicine
Chisinau , , Moldova, Republic of More Info
Vasile Musteata, MD, PhD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

52

Study ID:

NCT05544019

Recruitment Status:

Recruiting

Sponsor:


Schrödinger, Inc.

How clear is this clinincal trial information?

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