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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 15
- Primary Endpoint
- Frequency of occurrence and severity of DLT of S227928 alone in the first treatment cycle
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 18age old exceed to No limit (—)
Inclusion Criteria
- •1.Adult participant (must be over 18 years of age or according to local requirements).
- •Patients who are able to comply with the study procedures
- •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.
- •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.
- •Written informed consent must be obtained prior to any study-specific procedures.
Exclusion Criteria
- •1.Pregnant or lactating women.
- •WOCBP tested positive in a serum pregnancy test within 7 days prior to the first day of IMP administration.
- •Legally incapacitated person under guardianship or trusteeship.
Outcomes
Primary Outcomes
Frequency of occurrence and severity of DLT of S227928 alone in the first treatment cycle
Time Frame: First treatment cycle
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
Time Frame: 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)
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
Dose reduction/interruption/delay or discontinuation of the study due to adverse events
Secondary Outcomes
No secondary outcomes reported