A first-in-human, phase 1, dose-escalation study will investigate the safety, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and/or recommended dose of SGR-2921 in patients with relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
The study, set to start in October 2023, is not yet recruiting.
Through exploratory cohorts and planned amendments, the study aims to evaluate additional pharmacokinetics, pharmacodynamics, preliminary antitumor activity, and the safety of SGR-2921, as well as the combination of SGR-2921 with other approved AML/MDS treatments, such as hypomethylating agents, BCL2 inhibitors, IDH inhibitors, and FLT3 inhibitors, in patients with AML or MDS.
The researchers plan to enroll approximately 50 adult participants with a confirmed diagnosis of relapsed/refractory AML or high-risk and very high-risk MDS; each must have a life expectancy of at least 8 weeks and an Eastern Cooperative Oncology Group performance status lower than or equal to 2.
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Those with active malignancies within 2 years prior to the first SGR-2921 dose or in need of ongoing treatment will not be considered eligible for the study, nor will those with central nervous system or pulmonary leukostasis, active central nervous system leukemia, and grade 3 or higher disseminated intravascular coagulation. Patients with a QT interval corrected for heart rate per Fridericia’s formula of 470 msec or more during a screening electrocardiograph or those treated with an experimental drug or anticancer therapy within 14 days or 5 half-lives of the first dose of study drug will also be excluded.
According to the study design, the researchers will evaluate up to 9 SGR-2921 oral dose levels in a group of patients treated with specific azole antifungal treatment and a group of patients not receiving specific azole antifungal therapy.
The researchers will analyze dose-limiting toxicities from the first dose until the end of the first cycle (approximately 28 days, up to 42 days) as well as adverse events and electrocardiograms in singlicate and triplicate throughout the study (up to 26 months) as primary outcome measures.
The secondary outcome measures will include the maximal and minimum plasma concentrations of SGR-2921, time to maximal SGR-2921 concentration, SGR-2921 area under the concentration versus time curve, composite complete remission rate for patients with AML, the objective response rate for patients with AML or MDS, and the duration of response for people with AML or MDS throughout the study and up to 26 months.
The study, which is sponsored by Schrödinger, Inc., is set to be completed by December 2025.
Study of SGR-2921 in relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome. ClinicalTrials.gov. July 27, 2023. Updated August 3, 3023. Accessed August 11, 2023.