Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies

The total study duration per patient is up to 28 months including an up to 28 days screening
period, an up to 24 months treatment period, and a 3 months safety follow up period.

Inclusion criteria :

- Patients must have a known diagnosis of either unresectable hepatocellular carcinoma
(HCC), platinum-refractory recurrent/metastatic squamous cell carcinoma of the head
and neck (SCCHN), platinum-resistant/refractory epithelial ovarian cancer (EOC) with
evidence of measurable disease or recurrent glioblastoma multiforme (GBM).

- ≥18 years of age.

- For patients with HCC: Documentation of progressive disease (PD) during or after
treatment with either sorafenib or lenvatinib, or intolerance to the therapy.

- For patients with SCCHN: Received and failed up to 2 lines of prior systemic
anti-cancer therapy with documentation of tumor recurrence or PD within 6 months of
last platinum-based therapy in primary, recurrent, or metastatic setting.

- For patients with EOC: Received and failed up to 3 lines of prior platinum-containing
therapy when the disease was platinum-sensitive, and the patients should not have
received any systemic therapy for platinum-resistant/refractory disease.

- For patients with GBM: Documentation of PD or first recurrence during or after
temozolomide maintenance therapy for newly diagnosed GBM treated with 1st line
radiotherapy plus concurrent temozolomide.

Exclusion criteria:

- Prior exposure to agent that blocks CD38 or participation in clinical studies with
isatuximab.

- For patients with HCC, SCCHN, EOC or GBM prior exposure to any agent (approved or
investigational) that blocks the PD-1/PD-L1 pathway.

- Evidence of other immune related disease /conditions.

- History of non-infectious pneumonitis requiring steroids or current pneumonitis;
history of the thoracic radiation.

- Has received a live-virus vaccination within 28 days of planned treatment start.
Seasonal flu vaccines that do not contain live virus are permitted.

- Prior solid organ or bone marrow transplantation.

- Eastern Cooperative Oncology Group performance status (PS) ≥2 for patients with HCC,
SCCHN or EOC or Karnofsky performance score ≤ 70 for patients with GBM.

- Poor bone marrow reserve.

- Poor organ function.

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