Acute Myeloid LeukemiaPhase 1NCT05961839
Study of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
A Phase 1 study testing SGR-2921 in people with Acute Myeloid Leukemia and High-Risk and Very High-Risk Myelodysplastic Syndromes, run by Schrödinger, Inc. at 12 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, High-Risk and Very High-Risk Myelodysplastic Syndromes
- What is being tested?
- SGR-2921
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 12 sitesUnited States
- Study dates
- 27 Sep 2023to 9 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age.
- Life expectancy ≥ 8 weeks.
- Confirmed diagnosis of R/R AML or High Risk (HR) and Very High Risk (VHR) MDS.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Who cannot join
- Active malignancies within two years prior to the first dose, or requiring ongoing treatment, not related to AML or MDS.
- Clinical evidence of central nervous system (CNS) or pulmonary leukostasis, ≥ Grade 3 disseminated intravascular coagulation, or active CNS leukemia.
- Use of experimental drug, or therapy, or anti-cancer therapy within 14 days or 5 half-lives of the first dose of study drug.
- QT interval corrected for heart rate per Fridericia's formula ≥470 msec during screening ECG.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
St. David's South Austin Medical Center
Austin, Texas, 78745
Roswell Park Cancer Institute
Buffalo, New York, 14263
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus, Ohio, 43210
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401
The University of Kansas Clinical Research Center
Fairway, Kansas, 66205
MD Anderson Cancer Center
Houston, Texas, 77030
TriStar Bone Marrow Transplant, LLC
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
Philadelphia, Pennsylvania, 19107
Oregon Health & Science University - Knight Cancer Institute - Center of Hematologic Malignancies
Portland, Oregon, 97239
About this study
Official title: A First-In-Human, Phase 1, Dose Escalation Study of SGR-2921 as Monotherapy In Subjects With Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
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.
Read the detailed description
This is a study of SGR-2921, an oral, small molecule inhibitor of cell division cycle 7-related protein kinase (CDC7), in subjects with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) and/or recommended dose (RD) of SGR-2921.
Exploratory cohorts may evaluate additional PK, PD, preliminary anti-tumor activity, and safety to establish the SGR-2921 RD. A planned amendment will evaluate SGR-2921 in combination with other approved AML/MDS treatments such as hypomethylating agents (HMA), BCL2 inhibitors, IDH inhibitors or FLT3 inhibitors, in patients with AML and/or MDS.
- Being tested
- SGR-2921
- Keywords
- MDS, Relapsed or Refractory AML
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGR-2921Drug
SGR-2921 will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation in the Absence of Specific Azole Antifungal Treatments | Experimental | Up to 9 dose levels will be evaluated in subjects not receiving specific azole antifungal treatment. Receives: Drug: SGR-2921 |
| Dose Escalation in the Presence of Specific Azole Antifungal Treatments | Experimental | Up to 9 dose levels will be evaluated in subjects receiving specific azole antifungal treatment. Receives: Drug: SGR-2921 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities
Measured: From first dose until the end of Cycle 1 (approximately 28 days, up to 42 days).
Adverse Events
Incidence, nature, and severity of adverse events (AEs) as assessed by the NCI CTCAE v5.0.
Measured: Throughout the study, up to 26 months.
Electrocardiograms in Singlicate and Triplicate
Uncorrected QT interval, QTcF, PR duration, QRS interval, and RR interval.
Measured: Throughout the study, up to 26 months.
Secondary outcomes (9)
SGR-2921 Maximal Plasma Concentration (Cmax)
Concentrations of SGR-2921 in plasma are measured at various timepoints following its administration to calculate typical exposure/PK parameters, including, but not limited to, the maximal plasma concentration (Cmax).
Measured: Throughout the study, up to 26 months.
SGR-2921 Minimum Plasma Concentration (Cmin)
Concentrations of SGR-2921 in plasma are measured at various timepoints following its administration to calculate typical exposure/PK parameters, including, but not limited to, the minimum plasma concentration (Cmin).
Measured: Throughout the study, up to 26 months.
SGR-2921 Time to Maximal Plasma Concentration (tmax)
Concentrations of SGR-2921 in plasma are measured at various timepoints following its administration to calculate typical exposure/PK parameters, including, but not limited to, the time to maximal plasma concentration (tmax).
Measured: Throughout the study, up to 26 months.
SGR-2921 Area Under the Concentration Versus Time Curve (AUC)
Concentrations of SGR-2921 in plasma are measured at various timepoints following its administration to calculate typical exposure/PK parameters, including, but not limited to, the area under the concentration versus time curve (AUC).
Measured: Throughout the study, up to 26 months.
Composite Complete Remission (CR) Rate for Subjects with AML
The percentage of subjects with CR, CR with Partial Hematologic Recovery (CRh), and CR with Incomplete Blood Count Recovery (CRi).
Measured: Throughout the study, up to 26 months.
Objective Response Rate (ORR) for Subjects with AML
The percentage of subjects achieving CR, CRh, CRi, morphologic leukemia-free state (MLFS) and Partial Response (PR).
Measured: Throughout the study, up to 26 months.
Objective Response Rate (ORR) for Subjects with MDS
The percentage of subjects achieving CR and PR.
Measured: Throughout the study, up to 26 months.
Duration of Response (DOR) for Subjects with AML
The time from first response (CR, CRh, CRi, MLFS, or PR) to the date of initial objectively documented progression or death due to any cause, whichever occurs first.
Measured: Throughout the study, up to 26 months.
Duration of Response (DOR) for subjects with MDS
The time from first response (CR or PR) to the date of initial objectively documented progression or death due to any cause, whichever occurs first.
Measured: Throughout the study, up to 26 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start27 Sep 2023
- Primary completion14 Aug 2025
- Study completion9 Sep 2025
Why it stopped: Company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schrödinger, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Weiss, M.D., Study director, Schrödinger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961839
- Sponsor's protocol ID
- SGR-2921-101
- Status last verified
- Sep 2025
- First submitted
- 17 Jul 2023
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-In-Human, Phase 1, Dose Escalation Study of SGR-2921 as Monotherapy In Subjects With Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT05961839
- Acronym / sponsor ID
- SGR-2921-101
- Keywords
- MDS, Relapsed or Refractory AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Schrödinger, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 14 Aug 2025 (actual)
- Study completion
- 9 Sep 2025 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a study of SGR-2921, an oral, small molecule inhibitor of cell division cycle 7-related protein kinase (CDC7), in subjects with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) and/or recommended dose (RD) of SGR-2921.
Exploratory cohorts may evaluate additional PK, PD, preliminary anti-tumor activity, and safety to establish the SGR-2921 RD. A planned amendment will evaluate SGR-2921 in combination with other approved AML/MDS treatments such as hypomethylating agents (HMA), BCL2 inhibitors, IDH inhibitors or FLT3 inhibitors, in patients with AML and/or MDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation in the Absence of Specific Azole Antifungal Treatments | Experimental | Drug: SGR-2921Up to 9 dose levels will be evaluated in subjects not receiving specific azole antifungal treatment. |
| Dose Escalation in the Presence of Specific Azole Antifungal Treatments | Experimental | Drug: SGR-2921Up to 9 dose levels will be evaluated in subjects receiving specific azole antifungal treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years of age.
- Life expectancy ≥ 8 weeks.
- Confirmed diagnosis of R/R AML or High Risk (HR) and Very High Risk (VHR) MDS.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Key exclusion criteria (4 listed)
- Active malignancies within two years prior to the first dose, or requiring ongoing treatment, not related to AML or MDS.
- Clinical evidence of central nervous system (CNS) or pulmonary leukostasis, ≥ Grade 3 disseminated intravascular coagulation, or active CNS leukemia.
- Use of experimental drug, or therapy, or anti-cancer therapy within 14 days or 5 half-lives of the first dose of study drug.
- QT interval corrected for heart rate per Fridericia's formula ≥470 msec during screening ECG.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGR-2921SGR-2921 will be administered orally. | Drug | Dose Escalation in the Absence of Specific Azole Antifungal Treatments, Dose Escalation in the Presence of Specific Azole Antifungal Treatments |
Primary outcome
Dose Limiting Toxicities
Time frame: From first dose until the end of Cycle 1 (approximately 28 days, up to 42 days).
Adverse Events
Time frame: Throughout the study, up to 26 months.
Incidence, nature, and severity of adverse events (AEs) as assessed by the NCI CTCAE v5.0.
Electrocardiograms in Singlicate and Triplicate
Time frame: Throughout the study, up to 26 months.
Uncorrected QT interval, QTcF, PR duration, QRS interval, and RR interval.
9 secondary outcomes
SGR-2921 Maximal Plasma Concentration (Cmax)
Time frame: Throughout the study, up to 26 months.
SGR-2921 Minimum Plasma Concentration (Cmin)
Time frame: Throughout the study, up to 26 months.
SGR-2921 Time to Maximal Plasma Concentration (tmax)
Time frame: Throughout the study, up to 26 months.
SGR-2921 Area Under the Concentration Versus Time Curve (AUC)
Time frame: Throughout the study, up to 26 months.
Composite Complete Remission (CR) Rate for Subjects with AML
Time frame: Throughout the study, up to 26 months.
Objective Response Rate (ORR) for Subjects with AML
Time frame: Throughout the study, up to 26 months.
Objective Response Rate (ORR) for Subjects with MDS
Time frame: Throughout the study, up to 26 months.
Duration of Response (DOR) for Subjects with AML
Time frame: Throughout the study, up to 26 months.
Duration of Response (DOR) for subjects with MDS
Time frame: Throughout the study, up to 26 months.
Results and safety
The study was stopped early (reason given: Company decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Weiss, M.D. study director
Schrödinger, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SGR-2921 in people with Acute Myeloid Leukemia and High-Risk and Very High-Risk Myelodysplastic Syndromes, run by Schrödinger, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Company decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (time frame: From first dose until the end of Cycle 1 (approximately 28 days, up to 42 days).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.