SGR-2921 for Leukemia and Preleukemia

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, SGR-2921 (a CDC7 inhibitor), to determine its safety and the optimal dose for treating leukemia and preleukemia. Researchers will evaluate the drug on two groups: one using specific antifungal medications and one not using them. Suitable candidates have a confirmed diagnosis of certain types of leukemia or preleukemia that have returned or are difficult to treat. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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.

Is there any evidence suggesting that SGR-2921 is likely to be safe for humans?

Research has shown that SGR-2921, a treatment once tested for leukemia, had safety problems. In one study, two patients died, and their deaths were linked to this treatment. As a result, further development of SGR-2921 was stopped. These findings suggest that SGR-2921 may pose serious safety risks, which is important to consider if you are thinking about joining a trial with this treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SGR-2921 is unique because it offers a fresh approach to treating leukemia and preleukemia by exploring how the drug interacts with azole antifungal treatments. Unlike standard chemotherapy or targeted therapies, SGR-2921 is being tested in two different scenarios: with and without specific azole antifungals, which could reveal new ways to enhance its effectiveness. Researchers are particularly excited about the potential for SGR-2921 to work in harmony with these antifungals, potentially overcoming resistance issues seen with current treatments. This dual approach might offer a more personalized treatment strategy for patients, paving the way for improved outcomes.

What evidence suggests that SGR-2921 might be an effective treatment for leukemia?

Research has shown that SGR-2921 blocks a protein crucial for cell division. In lab tests, it effectively stopped cancer cells from growing, particularly in diseases like acute myeloid leukemia (AML). Early human studies indicated some potential against leukemia. However, serious safety concerns arose, as the treatment was linked to severe side effects in a few cases. This trial will explore different dose levels of SGR-2921, comparing one group receiving specific azole antifungal treatments with another group not receiving these treatments, to further assess its safety and effectiveness. ^{1 2 3 5 6}

Who Is on the Research Team?

Daniel Weiss, M.D.

Principal Investigator

Schrödinger, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Citations

1. ir.schrodinger.com ir.schrodinger.com/press-releases/news-details/2025/Schrdinger-Announces-Discontinuation-of-SGR-2921-Program/default.aspx

Schrödinger Announces Discontinuation of SGR-2921 Program The Phase 1 study was supported by preclinical data which had demonstrated that CDC7 inhibition resulted in monotherapy and combination anti ...

2. biopharmatrend.com biopharmatrend.com/news/schrodinger-ends-cdc7-inhibitor-program-following-two-patient-deaths-in-aml-trial-1344/

Schrödinger Ends CDC7 Inhibitor Program Following Two ... Initial Phase 1 data showed a favorable safety profile and preliminary efficacy signals. SGR-3515 (Wee1/Myt1 inhibitor) – A dual inhibitor ...

3. onclive.com onclive.com/view/clinical-development-is-discontinued-for-sgr-2921-in-r-r-aml-and-higher-risk-mds

Clinical Development Is Discontinued for SGR-2921 in R/R ... In vitro, SGR-2921 exhibited greater potency compared with other clinical-stage CDC7 inhibitors and showed antiproliferative activity in AML ...

4. fiercebiotech.com fiercebiotech.com/biotech/schrodinger-abandons-cdc7-inhibitor-after-therapy-linked-2-patient-deaths

Schrödinger abandons CDC7 inhibitor linked to 2 patient ... Schrödinger is abandoning its CDC7 inhibitor after the therapy was linked to the deaths of two patients in a phase 1 leukemia trial.

5. clin.larvol.com clin.larvol.com/trial-detail/NCT05961839

Study of SGR-2921 in Relapsed/Refractory Acute Myeloid ... Schrödinger also continues to advance its Phase 1 study of SGR-2921, its CDC7 inhibitor, in patients with acute myeloid leukemia (AML) or myelodysplastic ...

6. clinicaltrialsarena.com clinicaltrialsarena.com/news/schrodinger-ends-development-of-blood-cancer-drug-after-patient-deaths/

Schrödinger ends development of blood cancer drug after ... Schrödinger is discontinuing the development of its blood cancer CDC7 inhibitor after two patient deaths. In a Phase I trial (NCT05961839), ...