NIPH Clinical Trials Search

Phase 1/2 study of S227928 alone and in combination with Benetoclax in patients with R/R AML, MDS/AML or CMML

Basic Information

Recruitment status	Not Recruiting
Health condition(s) or Problem(s) studied	R/R AML, MDS/AML, or CMML
Date of first enrollment	30/05/2025
Target sample size	15
Countries of recruitment	Australia,Japan,United States of America,Japan,Finland,Japan,France,Japan,Germany,Japan
Study type	Interventional
Intervention(s)	In the dose-escalation portion of the study, Group A will receive S227928 intravenously at a starting dose of 3 mg/kg and six doses (3, 6, 9, 12, 16, and 20 mg/kg) at 2-week intervals, while Group B will receive S227928 intravenously at a starting dose of 3 mg/kg at 2-week intervals for the combination use with venetoclax. Only those dose levels of S227928 deemed safe and tolerable in Group A will be considered. Dosage and administration are subject to change based on new data obtained during the trial. In the dose escalation part, the recommended Phase II dose of S227928 in combination with venetoclax determined in the dose escalation part will be administered.

Outcome(s)

Primary Outcome

Frequency of occurrence and severity of DLT of S227928 alone in the first treatment cycle Incidence frequency and severity of DLTs for S227928 in combination with Benetoclax in the first treatment cycle Frequency of adverse events (AEs) and serious adverse events (SAEs), vital signs, physical examination, laboratory tests (including cardiac markers), electrocardiogram (ECG), echocardiography (ECHO) (with or without global longitudinal strain [GLS] measurements) or multigate acquisition method (MUGA) scan, and Cardiac nuclear magnetic resonance imaging (MRI) changes Dose reduction/interruption/delay or discontinuation of the study due to adverse events

Secondary Outcome

PK Parameters ADA detection and titer Complete response (CR)

Key inclusion & exclusion criteria

Age minimum	> 18age old
Age maximum	Not applicable
Gender
Include criteria	1.Adult participant (must be over 18 years of age or according to local requirements). 3. Patients who are able to comply with the study procedures 4. Women of childbearing potential (WOCBP) must use highly effective contraception during and for at least 6 months after the last dose of study drug. If oral contraceptives are used, they must be on a stable dose of the same contraceptive (same active ingredient) for at least 3 months prior to the first dose of study drug. Egg donation is not permitted during the study and for at least 6 months after the last dose of study drug. 5. Male subjects with WOCBP partners must use condoms during and for at least 3 months after the last dose of study drug. In addition, contraception for the female partner should be considered. Contraception is not required if the subject is infertile, post-vasectomy, or sexually abstinent. Sperm donation is not permitted during the study and for at least 6 months after the last dose of study drug. 6. Written informed consent must be obtained prior to any study-specific procedures.
Exclude criteria	1.Pregnant or lactating women. 2.WOCBP tested positive in a serum pregnancy test within 7 days prior to the first day of IMP administration. 3.Legally incapacitated person under guardianship or trusteeship.