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SAR443216 IV
Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors
Ensayo de Sanofi en Neoplasm Malignant · Breast Cancer · Lung Neoplasm Malignant · Gastric Cancer · Neoplasm (del registro, en inglés).
Más ensayos de: Cáncer de mama · Cáncer gástrico.
- Fase
- Fase 1
- Estado
- Interrumpido
- Participantes
- 44
- Centros
- 11
- Fin del objetivo primario
- ene 2024
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en ago 2021.
Qué mide
Part 1: Dose Escalation Determine the MTD/maximum administered dose (MAD) and RD(s) of SAR443216 (Cycle 1, cycle duration is 28 days for 2-week lead-in schedule and 35 days for 3-week lead-in schedule) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objectives: Part 1 (Dose Escalation) * To determine the MTD/maximum administered dose (MAD) of SAR443216 administered as a single agent in participants with HER2 expressing solid tumors and determine the RD(s) for intravenous (IV) and subcutaneous (SC) administration in the dose escalation part. * To determine the safety of SAR443216 after intravenous (IV) and subcutaneous (SC) administration. Part 2 (Dose expansion) • To assess preliminary clinical activity of single agent SAR443216 at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression. Secondary Objectives: Part 1 • To assess preliminary clinical activity of single agent SAR443216 after IV and SC administration at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression. Part 2 • To determine the safety of SAR443216. Part 1 and 2 * To characterize the pharmacokinetic (PK) profile of SAR443216 when administered as a single agent after IV and SC (Part 1 only) administration. * To evaluate the immunogenicity of SAR443216 after IV and SC administration. * To assess preliminary clinical activity of single agent SAR443216 at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05013554), actualizada en sep 2025.