Phase Ib Study of Anetumab Ravtansine in Combination With Pemetrexed and Cisplatin in Mesothelin-expressing Solid Tumors

Inclusion Criteria:

- Subjects may be male or female, and must be aged =/>18 years on the date of signing
the informed consent form.

- Subjects must have histologically confirmed, unresectable, locally advanced or
metastatic pleural or peritoneal predominantly (>50% of tumor component) epithelial
mesothelioma or nonsquamous non-small-cell lung cancer (NSCLC). Both
chemotherapy-naive and previously treated subjects will be eligible; however, newly
diagnosed NSCLC subjects eligible for FDA-approved therapies should have received the
same before enrollment (e.g. subjects with epidermal growth factor receptor
[EGFR]-mutated and anaplastic lymphoma kinase [ALK]-translocated NSCLC should have
received FDA-approved targeted therapies).

- Subjects must have at least 1 measurable or evaluable tumor lesion according to RECIST
1.1 (for nonsquamous NSCLC) or mRECIST (for epithelial pleural mesothelioma). Subjects
with resected primary tumors who have documented metastases are eligible.

- Subjects must have a life expectancy of at least 12 weeks.

- Subjects must have ECOG (Eastern Cooperative Oncology Group performance Status of 0 or
1

- Subjects must have adequate bone marrow, liver, kidney, and coagulation functions.

Exclusion Criteria:

- Subjects who have a previous or concurrent cancer that is distinct in primary site or
histology from the cancer being evaluated in this study, or any previous cancer
curatively treated >3 years before the start of study Treatment.

- Subjects who have a history or current evidence of bleeding disorder, i.e. any
hemorrhage / bleeding event of CTCAE (Common Terminology Criteria for Adverse Events)
Grade ≥2 within 4 weeks before the start of study Treatment.

- Subjects who have new or progressive brain or meningeal or spinal metastases.

- Subjects who have a history or current evidence of uncontrolled cardiovascular disease
i.e. NYHA (New York Heart Association) Class III or IV.

- Subjects who have a history or current evidence of uncontrolled hypertension defined
as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at
screening despite optimal medical management.

- Subjects who have a history or current evidence of malignant biliary obstruction
requiring biliary stent.

- Subjects who have had solid organ or bone marrow Transplantation.

- Subjects who have a history of hypersensitivity to any of the study drugs or their
excipients, or a history of severe hypersensitivity to any other Antigen.

- Subjects who have a history of human immunodeficiency virus (HIV) infection or
subjects who have an active hepatitis B virus (HBV) or hepatitis C virus (HCV)
infection requiring treatment.

- Subjects who have an active clinically serious infection of CTCAE Grade ≥2 or
non-healing wound unrelated to the primary Tumor.

- Subjects who have received systemic cancer therapy, radiotherapy, investigational drug
treatment outside of this study within 4 weeks before the start of study treatment,
granulocyte colony stimulating factors, (G-CSF) or granulocyte macrophage-stimulating
factors (GM-CSF), erythropoietin-stimulating agents within 3 weeks before the start of
general screening, drugs with known renal toxicity and strong cytochrome P450 3A4
(CYP3A4) inhibitors or strong CYP3A4 inducers within 2 weeks before the treatment.

- Subjects who have started oral or parenteral anticoagulation therapy within 2 weeks
before the start of anetumab ravtansine until end of treatment visit.