Study of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Purpose
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.
Conditions
- Acute Myeloid Leukemia
- High-Risk and Very High-Risk Myelodysplastic Syndromes
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- ≥ 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.
Exclusion Criteria
- 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dose Escalation in the Absence of Specific Azole Antifungal Treatments |
Up to 9 dose levels will be evaluated in subjects not receiving specific azole antifungal treatment. |
|
|
Experimental Dose Escalation in the Presence of Specific Azole Antifungal Treatments |
Up to 9 dose levels will be evaluated in subjects receiving specific azole antifungal treatment. |
|
Recruiting Locations
Fairway, Kansas 66205
More Details
- Status
- Recruiting
- Sponsor
- Schrödinger, Inc.
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.