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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study, up to 2 years.
Awards & highlights

Study Summary

This trial will test a new drug to see if it's safe and how much can be used safely.

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.Check my eligibility
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).See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Nature and number of incidences of dose limiting toxicity (DLT).
Therapeutic procedure
Secondary outcome measures
Disease Control Rate
Duration of Response (DOR)
Effect of Food on the AUC of SGR-1505
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: FE/DDI CohortExperimental Treatment1 Intervention
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.
Group II: Dose EscalationExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

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

Media Library

SGR-1505 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05544019 — Phase 1
MALT Lymphoma Research Study Groups: Dose Escalation, FE/DDI Cohort
MALT Lymphoma 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to participate in this research initiative?

"According to the information from clinicaltrials.gov, this study has been open for recruitment since October 1st 2022 and was recently updated on October 12th 2022, indicating it is still actively searching for patients."

Answered by AI

What are the primary objectives of this experiment?

"According to the study sponsor, Schrödinger Inc., this trial will assess Nature and number of incidences of dose limiting toxicity (DLT) for up to 2 years. In addition, SGR-1505 Area Under the Concentration Versus Time Curve (AUC), Effect of Posaconazole on the Cmax of SGR-1505, and Objective Response Rate (ORR) will be monitored as secondary measures throughout the course of study. AUC denotes plasma concentrations over time while Cmax is a measure of highest concentration in plasma following administration alone or with an inhibitor such as Posaconazole. Finally ORR"

Answered by AI

How many participants are being included in this medical research?

"Indeed, the information found on clinicaltrials.gov affirms that this investigation is still searching for participants. This study was initially advertised on October 1st 2022 and was most recently revised in October 12th 2022. 52 patients must be sourced from a single medical centre to complete the trial."

Answered by AI

To what extent can Dose Escalation be detrimental to human health?

"The safety of Dose Escalation is estimated at 1, due to the limited information available in this Phase 1 trial concerning its efficacy and security."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Study of SGR-1505 in Mature B-Cell Neoplasms
2023. "Study of SGR-1505 in Mature B-Cell Neoplasms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05544019.
All > Waldenstrom Macroglobulinemia
~24 spots leftby Mar 2025
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