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 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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Part 1: Dose Escalation Determine the MTD/maximum administered dose (MAD) and RD(s) of SAR443216
Timeframe: Cycle 1, cycle duration is 28 days for 2-week lead-in schedule and 35 days for 3-week lead-in schedule
Part 1: Dose Escalation: Safety of SAR443216
Timeframe: Baseline until end of study, up to approximately 7.5 months
Part 2: Dose Expansion Objective response rate (ORR) of SAR443216 in all participants
Timeframe: From date of enrollment until the end of treatment, up to approximately 5.5 months
Part 2: Dose Expansion Duration of response (DoR) of SAR443216 in all participants.
Timeframe: From date of enrollment until the end of treatment, up to approximately 5.5 months