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SGR-1505 for B-Cell Lymphoma

Phase 1
Recruiting
Research Sponsored by Schrödinger, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Must not have
Subject has previous invasive malignancy in the last 2 years.
Subject has symptomatic or active CNS involvement of disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study, up to 2 years.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing SGR-1505, a new oral drug that blocks a protein called MALT1, in patients with B-cell lymphomas that have returned or did not respond to previous treatments. The goal is to find the safest and most effective dose while also seeing how well it works against the cancer.

Who is the study for?
This trial is for people with various types of mature B-cell cancers, like lymphoma and leukemia. Participants must have a confirmed diagnosis, measurable disease, be relatively active (ECOG 0-2), and expected to live at least 12 weeks. They can't join if they've had another cancer in the last 2 years or need immediate treatment for indolent NHL/CLL unless out of options.
What is being tested?
The study is testing SGR-1505's safety and how well patients tolerate it. It aims to find the highest dose patients can handle without severe side effects (MTD) or suggest an optimal dose for further research (RD).
What are the potential side effects?
Specific side effects are not listed but generally could include reactions related to immune system activation, infusion-related symptoms, fatigue, digestive issues, blood disorders, or increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My disease can be measured or detected with tests.
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I can take care of myself and am up and about more than half of my waking hours.
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I have a confirmed diagnosis of mature B-cell cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had cancer that spread into surrounding tissues within the last 2 years.
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My cancer has spread to my brain and is causing symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study, up to 2 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study, up to 2 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Nature and number of incidences of dose limiting toxicity (DLT).
Secondary study objectives
Disease Control Rate
Duration of Response (DOR)
Objective Response Rate (ORR)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose EscalationExperimental Treatment1 Intervention
Up to 9 dose levels in total will be evaluated across two dosing schedules. 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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Targeted therapies for Chronic Lymphocytic Leukemia (CLL) include agents like ibrutinib, venetoclax, and obinutuzumab. Ibrutinib inhibits Bruton's tyrosine kinase (BTK), reducing CLL cell survival and proliferation. Venetoclax targets BCL-2, promoting cancer cell death. Obinutuzumab, a monoclonal antibody, targets CD20 on B-cells, enhancing immune-mediated cell destruction. These treatments offer more precise options with potentially fewer side effects compared to traditional chemotherapy, improving patient outcomes and quality of life.
Targeting the tumor microenvironment in chronic lymphocytic leukemia.Diagnosis, treatment and supportive management of chronic lymphocytic leukemia: recommendations of the Dutch HOVON CLL working group.Targeted therapy in the treatment of chronic lymphocytic leukemia: facts, shortcomings and hopes for the future.

Find a Location

Who is running the clinical trial?

Schrödinger, Inc.Lead Sponsor
2 Previous Clinical Trials
102 Total Patients Enrolled
Daniel Weiss, M.D.Study DirectorSchrodinger Inc.
1 Previous Clinical Trials
50 Total Patients Enrolled
Frank G Basile, M.D.Study DirectorSchrodinger Inc.

Media Library

SGR-1505 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05544019 — Phase 1
Chronic Lymphocytic Leukemia Research Study Groups: Dose Escalation
Chronic Lymphocytic Leukemia Clinical Trial 2023: SGR-1505 Highlights & Side Effects. Trial Name: NCT05544019 — Phase 1
SGR-1505 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05544019 — Phase 1
~24 spots leftby Mar 2026