SGR-2921 for Leukemia and Preleukemia

Recruiting at 11 trial locations

Overseen By Study Physician

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Schrödinger, Inc.

Must not be taking: Experimental drugs

Disqualifiers: Active malignancies, CNS leukemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but you cannot use any experimental drugs or anti-cancer therapies within 14 days before starting the study drug.

What is the purpose of this trial?

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-2921.

Research Team

Daniel Weiss, M.D.

Principal Investigator

Schrödinger, Inc.

Eligibility Criteria

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.

Inclusion Criteria

I can take care of myself and am up and about more than 50% of my waking hours.

I have been diagnosed with relapsed or refractory AML or high/very high risk MDS.

Life expectancy ≥ 8 weeks

Exclusion Criteria

QT interval corrected for heart rate per Fridericia's formula ≥470 msec during screening ECG

I haven't used any experimental drugs or cancer treatments in the last 14 days.

I haven't had any cancer treatments in the last 2 years, except for AML or MDS.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive SGR-2921 at escalating doses to determine the maximum tolerated dose and/or recommended dose

26 months

Regular visits throughout the study

Exploratory Cohorts

Evaluation of additional pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity

26 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SGR-2921

Trial Overview 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).

Participant Groups

Group I: Dose Escalation in the Presence of Specific Azole Antifungal Treatments Experimental Treatment 1 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 Treatments Experimental Treatment 1 Intervention

Up to 9 dose levels will be evaluated in subjects not receiving specific azole antifungal treatment.

Who Is Running the Clinical Trial?

Schrödinger, Inc.

Lead Sponsor

Trials

3

Recruited

150+