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SAR443579
A Study to Investigate Natural Killer Cell Engager (SAR443579) With Different Agents in Participants With Hematological Malignancies
Ensayo de Sanofi en Leucemia mieloide aguda.
Más ensayos de: Leucemia mieloide aguda.
- Fase
- Fase 1/2
- Estado
- Interrumpido
- Participantes
- 7
- Centros
- 7
- Fin del objetivo primario
- ago 2025
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en ago 2024.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Early discontinuation based on strategic sponsor decision not driven by any safety concerns».
Qué mide
Number of participants with adverse events (AEs)/serious adverse events (SAEs)/adverse events of special interest (AESIs), laboratory abnormalities (Day 1 to 30 days after the last administration of study treatment) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a parallel, Phase 1/Phase 2, randomized, open label, multi-cohort, multi-center study assessing the safety, tolerability and preliminary efficacy of SAR443579 with different agents for treatment in adolescent and/or adult participants with CD123 expressing hematological malignancies. This protocol is structured as a master protocol (containing common protocol elements). Individual sub-studies will explore SAR443579 with combination partners, which may include approved or investigational agents. Experimental sub-studies will be tested through 3 parts: Part 1: dose finding (such as dose escalation/ safety run-in). Part 2: dose optimization (when applicable). Part 3: dose expansion. In each sub-study, a dose escalation will identify preliminary recommended dose for expansion (pRDE) of SAR443579 and its respective combination partner. Following the determination of the preliminary RDE, additional participants will be enrolled in the dose expansion part, or if dose optimization needs to be further evaluated, additional participants will be enrolled in the "dose optimization/expansion" part. Dose optimization and dose expansion part could involve randomization depending on specific sub-study design. Study will consist of a screening period, treatment period, and follow-up period. Participants will receive study treatment until documented disease progression, unacceptable adverse events, participant's decision to stop study treatment, or completion of the maximum cycles allowed in the sub-studies, or the participant meets other criteria for discontinuation per study protocol (whichever occurs first).
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06508489), actualizada en ago 2025.