A Phase I Study of LXS196 in Patients With Metastatic Uveal Melanoma.

Key Inclusion Criteria:

- Male or female patients ≥18 years of age

- Diagnosis of uveal melanoma with histological or cytological confirmed metastatic
disease. Disease must be treatment naive or have progressed (radiologically or
clinically) on most recent therapy.

- Willingness to provide newly obtained tumor tissue at baseline and on treatment unless
contraindicated by medical risk in the opinion of the treating physician.

- Measurable disease, defined as at least one lesion that can be accurately measured in
at least one dimension (longest diameter to be recorded) as > 20 mm with conventional
techniques or as >10 mm with CT scan.

- ECOG performance status ≤ 1

Key Exclusion Criteria:

- Malignant disease other than that being treated in this study.

- Symptomatic or untreated CNS metastases or spinal cord compression. Brain metastasis
must be stable with verification by imaging .

- Impaired cardiac function or clinically significant cardiac diseases

- History of thromboembolic or cerebrovascular events within the last 6 months,
including transient ischemic attack, cerebrovascular accident, deep vein thrombosis,
or pulmonary embolism (applicable to combination part only).

- Patients who are receiving treatment with medications that cannot be discontinued
prior to study entry and that are considered to be any of the following:

- known and possible risk for QT prolongation

- known to be strong inducers or inhibitors of CYP3A4/5 (for single agent part); known
to be moderate to strong inducers or inhibitors of CYP3A4/5 (for combination part)

- known to be inducers or inhibitors of P-gp

- known to be substrates of CYP3A4/5 and P-gp with a narrow therapeutic index

- Patients with abnormal laboratory values, defined as any of the following:

- AST or ALT > 3 times ULN, AST or ALT > 5 times ULN for patients with liver metastases.

- Total bilirubin > 1.5 x ULN, except for patients with Gilbert's syndrome who are
excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN.

- Absolute neutrophil count (ANC) ≤ 1.5 x109/L.

- Platelets ≤ 100 x 109/L.

- Hemoglobin (Hgb) ≤ 90 g/L (9 g/dL).

- Creatinine > 1.5 x ULN

- Patients receiving live vaccines due to the expected bone marrow toxicity (applicable
to combination part only).

- Patients treated with growth factors targeting the myeloid lineage (e.g. G-CSF, GM-CSF
and M-CSF) within 2 weeks of starting study treatment. (applicable to combination part
only).