Phase I Study to Determine the Maximum Tolerable Dose of BAY94-9343 in Patients With Advanced Solid Tumors.

Inclusion Criteria:

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

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1

- Life expectancy of at least 12 weeks

- Histologically or cytologically documented invasive epithelial ovarian, primary
peritoneal, or fallopian tube cancer (tumors with pseudomyxomatous or mucinous
histology are excluded) or advanced predominantly epithelioid peritoneal mesothelioma.

-- Ovarian cancer must have relapsed >0 months and ≤ 12 months of the prior
platinum-based chemotherapy regimen (platinum resistant and partially platinum
sensitive).

- All patients must provide the tumor tissue sample [Formalin Fixed Paraffin Embedded
(FFPE) slides] from archival tissue or fresh biopsy collected any time before the
general screening under the separate informed consent.

- Mesothelin expression in the tumor tissue from archival or fresh biopsy samples
defined as the membrane intensity score of 2+ or 3+ (on the 0-3 scale) expressed on at
least 30% of tumor cells.

-- Mesothelin expression must be determined by the validated Investigational Use Only
(IUO) assay for ovarian cancer or the prototype immunohistochemistry (IHC) assay for
mesothelioma at Ventana at any time before the general screening in patients who had
signed a separate informed consent for tumor tissue analysis for mesothelin
expression.

- No more than 3 prior lines of systemic cytotoxic therapy for patients with advanced
peritoneal or pleural mesothelioma or

- No more than 5 prior lines of systemic cytotoxic therapy for patients with ovarian
cancer

- Possible intraperitoneal administration of cytotoxics during surgery will not count as
systemic cytotoxic therapy in either case.

- Measurable disease with at least one lesion that can be accurately measured in at
least one dimension according to Response Evaluation Criteria In Solid Tumors (RECIST)
1.1.

exclusion Criteria:

- More than 3 prior lines of systemic cytotoxic therapy for patients with advanced
peritoneal or pleural mesothelioma

- More than 5 prior lines of systemic cytotoxic therapy for patients with ovarian cancer

- Other systemic anticancer therapies (molecular-targeted, immunotherapy etc.) may be
acceptable after the consultation between the Investigator and the Bayer Medical
Expert.

- Intraperitoneal administration of cytotoxic anticancer agents during tumor surgery
will not count as systemic cytotoxic therapy in this context.

- Prior local radiotherapy is allowed if it is completed at least 4 weeks prior to the
first dose of study drug and the subject has evaluable lesions not previously
irradiated.

- 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.

- Radiotherapy to the target lesions within 4 weeks prior to the first BAY94-9343
infusion, if the subject has evaluable tumor lesions not previously irradiated.

- Use of strong inhibitors of P-glycoprotein (transporter) (P-gp) (e.g., ritonavir,
cyclosporine, verapamil, and dronedarone) is prohibited from Day -14 and for the
duration of the study.

- Impaired cardiac function or clinically significant cardiac disease [i.e., congestive
heart failure (CHF) New York Heart Association (NYHA) Class III or IV].

- Left ventriculat ejection fraction (LVEF) <50 % [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.

- Mild blurry vision, either age-related or due to ocular or systemic disorder (e.g.
diabetes, dry eyes, cataracts, uncorrected refraction abnormality) may be allowed at
the discretion of the ophthalmologist if deemed as no constituting a predisposition to
drug-induced corneal deposits and blurry vision.