SGR-2921 for Leukemia and Preleukemia

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Schrödinger, Inc.

Must not be taking: Experimental drugs

Disqualifiers: Active malignancies, CNS leukemia, others

No Placebo Group

Trial Summary

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.

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.

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 am 18 years old or older.

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.

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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.

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Trial 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 (Other)

Trial OverviewThe 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

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.