A Phase I/Ib Trial for the Evaluation of SAR260301 in Monotherapy or in Combination With Vemurafenib in Patients With Various Advanced Cancer

Study duration for one patient will include a period for inclusion (screening period) of up
to 4 weeks, a treatment period of at least 4 weeks, and a end-of-study visit at 30 days
following the last administration of study drug. The patient may continue treatment until
disease progression, unacceptable toxicity or willingness to stop, followed by a minimum of
30-days follow-up.

Inclusion criteria :

- Age ≥18 years old

- Locally advanced or metastatic solid tumor disease as well as lymphoma for which no
alternative therapy is available (Part A)

- Unresectable / metastatic BRAF-mutated melanomas, progressing on BRAF inhibitor after
no more than 4 months treatment or with only partial response (<50% change in tumor
volume) after 4 months of treatment (Part B) or vemurafenib naive (Part B escalation
phase only): anterior scans must be available for patients having received BRAF
inhibitor prior to entry into the study.

- At least one measurable lesion by RECIST v1.1

- Archived primary tumor biopsies or surgical specimens, or biopsies of recurrence or
metastasis, will be requested for all subjects for predictive markers of response
analysis.

Exclusion criteria:

- ECOG performance status >1

- Concurrent treatment with any other anticancer therapy

- Patient with reproductive potential (female and male) who do not agree to use an
accepted effective method of contraception during the study treatment period and for
at least 6 months following completion of study treatment.

- Pregnancy or breast-feeding

- Any malignancy related to immunodeficiency virus (HIV) or solid organ transplant;
history of known HIV, unresolved viral hepatitis.

- Subjects with brain metastases of non-central nervous system (CNS) primary tumors are
excluded if their lesions are larger than 1 cm in the longest dimension, symptomatic
or changed in size in the latest scan compared to the previous scan. Subjects must
not require corticosteroid treatment or have received treatment for brain metastases
for at least one month prior to study entry.

- Inadequate haematological function.

- Inadequate renal function.

- Inadequate liver function.

- Non-resolution of any prior treatment related toxicity to < Grade 2, except for
alopecia according to National Cancer Institute Common Terminology Criteria for
Adverse Events (NCI CTCAE) v4.03.

- Any major surgery within the last 28 days.

- History of congenital platelet function defect or bleeding diathesis.

- Abnormal platelet function using platelet function assay PFA 100® including
aggregation time >122 seconds using the collagen/ADP cartridge, and/or >183 seconds
using the collagen/epinephrine cartridge.

- Current use of aspirin, clopidogrel, ticlopidine, prasugrel or ticagrelor.

- Abnormal coagulation parameters: Prothrombin time (PT)/ international normalized
ratio (INR) or activated partial thromboplastin time (aPTT) >1.3X ULN. Prophylactic
but not therapeutic anticoagulants are permitted.

- Any of the following within 6 months prior to study enrolment: peptic ulcer disease,
erosive oesophagitis, or gastritis, infectious or inflammatory bowel disease,
diverticulitis, GI perforation, intestinal obstruction and GI hemorrhage.

- Patients with history of chronic renal diseases, interstitial nephritis, or with
uncontrolled or unresolved acute renal failure.

- Hemoptysis within the past 3 months.

- Patients with known Gilbert's syndrome.

- Prior hypersensitivity reaction or severe dermatologic reactions such as Steven's
Johnsons syndrome and toxic epidermal necrolysis (TENS) to vemurafenib in Part B.

- Uveal melanoma as new primary malignancy in Part B

- Prior history or ongoing uveitis

- Mean QTc interval >470 msec (using QTcF formula) or any clinically significant QTc
prolongation, history of Torsade de Pointes or malignant arrhythmias or conduction
disturbances.

- Other clinically significant ECG abnormalities including 2nd degree (Mobitz Type II),
familial history of long QT syndrome and 3rd degree atrioventricular block.

- Congestive heart failure

- Uncontrolled or untreated hypertension

- Uncorrectable serum abnormalities for the following electrolytes: potassium,
magnesium and calcium.

- Medical conditions having to require concomitant administration of strong CYP3A4
inhibitors or inducers 2 weeks prior to study treatment or 5 elimination half-life of
the drug, whichever is longest.

- Medical conditions requiring concomitant administration of medications with a narrow
therapeutic window and metabolized by CYP1A2 or CYP2D6, and for which a dose
reduction cannot be considered.

- Medical conditions requiring concomitant administration of medications susceptible to
prolong QTc interval.

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