An Open Label Phase I Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Maximum Tolerated Dose of the Anti-mesothelin Antibody Drug Conjugate BAY94-9343 in Subjects With Advanced Solid Tumors

Inclusion Criteria:

- All subjects must be ≥ 18 years at the first screening examination / visit

- Eastern Cooperative Oncology Group Performance Status of 0 - 2

- Life expectancy of at least 12 weeks

- Subjects with advanced, histologically or cytologically confirmed solid tumors,
refractory to any standard therapy or with no standard therapy available

- Radiographically or clinically evaluable tumor

- Adequate bone marrow, liver, and renal function as assessed by the following
laboratory requirements to be conducted within 14 days prior to start of first dose:

- Hemoglobin ≥ 9.0 g/dL

- Absolute neutrophil count (ANC) ≥ 1500/mm3

- Platelet count ≥ 100,000 /mm3

- Total bilirubin ≤ 1.5 times the upper limit of normal

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x
upper limit of normal (ULN) (≤ 5 x upper limit of normal for subjects with liver
involvement)

- International normalized ratio (INR) and partial thromboplastin time (PTT) ≤ 1.5 x
ULN for subjects not undergoing anticoagulative treatment. Subjects undergoing
anticoagulative treatment with eg. warfarin or heparin, which was initiated at least
4 weeks prior to the planned start of treatment in this study and which is well
controlled with INR and PTT in therapeutic ranges, are eligible

- Serum creatinine ≤ 1.5 times ULN and glomerular filtration rate (GFR) ≥ 30
ml/min/1.73 m2, according to the MDRD (Modified Diet in Renal Disease) abbreviated
formula

Exclusion Criteria:

- Impaired cardiac function or clinically significant cardiac disease (ie, congestive
heart failure (CHF), New York Heart Association (NYHA) Class III or IV)

- Myocardial infarction or onset of unstable angina < 3 months prior to screening

- Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or
digoxin

- Left ventricular ejection fraction (LVEF) <40% (as measured at screening by multiple
gated acquisition scan (MUGA) or echocardiogram)

- Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg and/or
diastolic blood pressure > 90 mmHg, despite optimal medical management

- History of symptomatic metastatic brain or meningeal tumors unless the subject is > 3
months from definitive therapy

- Subjects with severe renal impairment or on dialysis

- Human immunodeficiency virus (HIV) infection or subjects with an active hepatitis B
or C infection necessitating treatment. Subjects with chronic hepatitis B or C are
eligible

- Active clinically serious infections > National Cancer Institute Common Terminology
Criteria Adverse Events (NCI CTCAE) Grade 2

- Serious, non-healing wound, ulcer, or bone fracture

- Known or suspected allergy or intolerance to any agent given in the course of this
trial

- Substance abuse, medical, psychological or social conditions that may interfere with
the subject's participation in the study or evaluation of the study result

- Major surgery, open biopsy, or significant trauma within 2 weeks prior to the planned
start of study treatment

- Anticancer chemotherapy, experimental cancer therapy, or immunotherapy within 2 weeks
of start of first dose. Anticancer therapy is defined as any agent or combination of
agents with clinically proven anti tumor activity administered by any route with the
purpose of affecting the malignancy, either directly or indirectly, including
palliative and therapeutic endpoints. Toxic effects of previous anticancer
chemotherapy, experimental cancer therapy, or immunotherapy have to be normalized
completely (excluding alopecia)

- Toxic effects considered as chronic, such as chemotherapy induced neuropathy of NCI
CTC AE grade ≤ 2, where anymore resolution is not expected, does not prevent subjects
from participation in the trial

- Radiotherapy to the target lesions within 3 weeks prior to Day 1, Cycle 1 (first dose
of study drug). Radiotherapy to the target lesions during study will be regarded as
progressive disease