Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors

Inclusion Criteria:

Participants must be ≥ 18 years of age
Histologically or cytologically confirmed diagnosis of metastatic solid tumors
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Participants must have HER2 expression in tumor tissue and/or with HER2 aberration detected in tumor or blood by means of validated assay(s)
Body weight within [45 - 150 kg] (inclusive)
Male and female participants including woman of childbearing potential must agree to follow contraceptive guidance
Capable of giving signed informed consent

Exclusion Criteria:

Any clinically significant cardiac disease
History of or current interstitial lung disease or pneumonitis
Uncontrolled or unresolved acute renal failure
Prior solid organ or hematologic transplant.
Known positivity with human immunodeficiency virus (HIV), known active hepatitis A, B, and C, or uncontrolled chronic or ongoing infectious requiring parenteral treatment.
Receipt of a live-virus vaccination within 28 days of planned treatment start
Participation in a concurrent clinical study in the treatment period.
Inadequate hematologic, hepatic and renal function
Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions.

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.