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SGR-2921 for Leukemia and Preleukemia
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study, up to 26 months.
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new drug to find what dose is safe and has the best result.
Who is the study for?
This trial is for adults over 18 with relapsed/refractory Acute Myeloid Leukemia or high-risk Myelodysplastic Syndrome. Participants should have a life expectancy of at least 8 weeks and be able to perform daily activities with some limitations (ECOG ≤2). Those who've had recent cancer treatments or other experimental drugs, heart rhythm issues, active cancers besides AML/MDS, severe blood clotting disorders, or leukemia in the brain/spine can't join.
What is being tested?
The study is testing SGR-2921's safety and how well patients tolerate it. It aims to find the highest dose that doesn't cause unacceptable side effects (MTD) and/or suggest a dose for future studies (RD).
What are the potential side effects?
Potential side effects are not specified but typically include reactions related to drug tolerance levels such as fatigue, nausea, allergic reactions, or more serious conditions depending on individual patient responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout the study, up to 26 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study, up to 26 months.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Events
Electrocardiograms in Singlicate and Triplicate
Secondary study objectives
Composite Complete Remission (CR) Rate for Subjects with AML
Duration of Response (DOR) for Subjects with AML
Duration of Response (DOR) for subjects with MDS
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose Escalation in the Presence of Specific Azole Antifungal TreatmentsExperimental Treatment1 Intervention
Up to 9 dose levels will be evaluated in subjects receiving specific azole antifungal treatment.
Group II: Dose Escalation in the Absence of Specific Azole Antifungal TreatmentsExperimental Treatment1 Intervention
Up to 9 dose levels will be evaluated in subjects not receiving specific azole antifungal treatment.
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Who is running the clinical trial?
Schrödinger, Inc.Lead Sponsor
2 Previous Clinical Trials
104 Total Patients Enrolled
Daniel Weiss, M.D.Study DirectorSchrödinger, Inc.
1 Previous Clinical Trials
52 Total Patients Enrolled