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