Atu027 Plus Gemcitabine in Advanced or Metastatic Pancreatic Cancer (Atu027-I-02)

Inclusion Criteria:

Lead-in safety period:

* Subjects between the age of 18 and 84 years
* Histologically or cytologically confirmed advanced or refractory cholangiocellular carcinoma, biliary tract cancer, non-small-cell lung carcinoma, duodenal cancer, soft tissue sarcoma, ovarian carcinoma, or another non-pancreatic cancer disease indicated for gemcitabine treatment as determined by the investigator
* Subjects who have previously received chemotherapy and standard curative or palliative care is not available, not effective, or unlikely to be effective
* No option for surgical resection or radiation in curative intent
* Eastern Cooperative Oncology Group (ECOG) performance status assessment of 0 to 2
* Life expectancy of at least 3 months
* No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
* Alanine aminotransferase (ALT) ≤3.0 x upper limit of normal (ULN; ≤5 x ULN for subjects with liver metastases)
* Aspartate aminotransferase (AST) ≤3.0 x ULN (≤5 x ULN for subjects with liver involvement with cancer)
* Total bilirubin ≤2.0 x ULN (liver metastasis \<5 x ULN)
* Serum creatinine ≤1.5 x ULN
* Adequate bone marrow function: subjects should have an absolute granulocyte count of at least 1,500 (x 10e6/L) and platelet count of 100,000 (x 10e6/L) prior to the initiation of a cycle.
* Prothrombin time-international normalized ratio/partial thromboplastin time (PT-INR/PTT) \<1.5 x ULN (subjects who are being therapeutically anti-coagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists). Low-dose aspirin is permitted (≤100 mg daily).
* Women of childbearing potential must have a negative urine pregnancy test at baseline.
* Women of childbearing potential and men must be willing to use highly effective contraceptive methods during the course of the study and 6 months after.
* Subjects must be willing and able (in the opinion of the investigator) to understand the subject information and informed consent form and to comply with the study protocol and procedures.
* Subjects must be willing and able to give written informed consent.

Main part:

* Subjects between the age of 18 and 84 years
* Subjects with locally advanced or metastatic pancreatic adenocarcinoma stage III/IV indicated for gemcitabine treatment as determined by the investigator
* No option for surgical resection or radiation in curative intent
* Histological or cytological documentation of non-hematologic, malignant solid tumor
* At least one measurable lesion or evaluable disease, as per the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status assessment of 0 to 2
* Life expectancy of at least 3 months
* No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
* Alanine aminotransferase (ALT) \<=3.0 x upper limit of normal (ULN; \<=5 x ULN for subjects with liver metastases)
* Aspartate aminotransferase (AST) \<=3.0 x ULN (\<=5 x ULN for subjects with liver involvement with cancer)
* Total bilirubin \<=2.0 x ULN (liver metastasis \<=5 x ULN)
* Serum creatinine \<=1.5 x ULN
* Adequate bone marrow function: subjects should have an absolute granulocyte count of at least 1,500 (x 10e6/L) and platelet count of 100,000 (x 10e6/L) prior to the initiation of a cycle.
* Prothrombin time-international normalized ratio/partial thromboplastin time (PT INR/PTT) \<1.5 x ULN (subjects who are being therapeutically anti-coagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists). Low-dose aspirin is permitted (≤100 mg daily).
* Women of childbearing potential must have a negative urine pregnancy test at baseline.
* Women of childbearing potential and men must be willing to use highly effective contraceptive methods during the course of the study and 6 months after.
* Subjects must be willing and able (in the opinion of the investigator) to understand the subject information and informed consent form and to comply with the study protocol and procedures.
* Subjects must be willing and able to give written informed consent.

Exclusion Criteria:

Lead-in safety period:

* History of cardiac disease; congestive heart failure \>New York Heart Association (NYHA) functional classification system Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset angina within 3 months prior to study entry or unstable angina, or ventricular cardiac arrhythmias requiring anti-arrhythmic therapy
* Poorly controlled diabetes defined as hemoglobin A1c (HbA1c) \>=7%
* Poorly controlled hypertension, defined as systolic blood pressure \>150 mmHg or diastolic pressure \>90 mmHg, despite optimal medical management
* Poorly controlled seizure disorder
* Subjects undergoing renal dialysis
* Known hypersensitivity to the study drugs or active substances or excipients of the preparations
* Pregnant or breast feeding
* Known hepatitis B or C or human immunodeficiency virus (HIV) infection (if documented in the subject's record
* Previous participation in this study
* Current or previous (within 30 days of enrolment) treatment with another investigational drug or participation in another clinical study.
* Subject is a relative of, or staff directly reporting to the investigator.
* Subject is an employee of the sponsor.
* Subject is committed under official or judicial order.
* Any other reason that the investigator considers makes the subject unsuitable to participate

Main part:

* History of cardiac disease; congestive heart failure \>New York Heart Association (NYHA) functional classification system Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset angina within 3 months prior to study entry or unstable angina, or ventricular cardiac arrhythmias requiring anti-arrhythmic therapy
* Poorly controlled diabetes defined as hemoglobin A1c (HbA1c) \>=8%
* Poorly controlled hypertension, defined as systolic blood pressure \>150 mmHg or diastolic pressure \>90 mmHg, despite optimal medical management
* Poorly controlled seizure disorder
* Subjects undergoing renal dialysis
* Anticancer chemotherapy or immunotherapy during the study or before first study treatment. Subjects with recurrent disease after adjuvant treatment not progression-free for at least 6 months.
* Radiotherapy to target lesions during study or before study start
* Known hypersensitivity to the study drugs or active substances or excipients of the preparations
* Pregnant or breast feeding
* Known hepatitis B or C or human immunodeficiency virus (HIV) infection (if documented in the subject's record
* Previous participation in this study
* Current or previous (within 30 days of enrolment) treatment with another investigational drug or participation in another clinical study.
* Subject is a relative of, or staff directly reporting to the investigator.
* Subject is an employee of the sponsor.
* Subject is committed under official or judicial order.
* Any other reason that the investigator considers makes the subject unsuitable to participate