Primary 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 RP2D 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 SAR4443216 at the RP2D 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 R2PD 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 R2PD in participants with HER2 expressing solid tumors, with various levels of HER2 expression.
Source: View full study details on ClinicalTrials.gov
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