臨床研究等提出・公開システム

Phase 1/2 Clinical Trial of S227928, an Anti-CD74 Antibody Drug Conjugate Targeting MCL-1, as a Single Agent and in Combination with Venetoclax in Patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)/AML, or Chronic Myelomonocytic Leukemia (CMML) (Phase 1/2 Clinical Trial of S227928 as a Single Agent and in Combination with Venetoclax in Patients with R/R AML, MDS/AML, or CMML)

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

Keagle Kristen

Research and Development Oncology and Immune Oncology Therapeutic Area

200 Pier Four Blvd, Boston, MA 02210

kristen.keagle@servier.com

ICTR- Japan

Nihon Servier Company Limited

Hongo MK building, 1-28-34 Hongo, Bunkyo-ku, Tokyo 113-0033 Japan

+81-3-8844-6127

clinicaltraials.jpn@servier.com

Not Recruiting

May. 30, 2025

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

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.

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.

R/R AML, MDS/AML, or CMML

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.

Myelodysplastic syndrome, acute myelogenous leukemia, chronic myelomonocytic leukemia

Oral and intravenous administration

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

PK Parameters
ADA detection and titer
Complete response (CR)

+81-3-3823-2101

Mar. 25, 2025

Australia/United States of America/Finland/France/Germany