First in Human Phase1/2a Clinical Trial of Anti-PAUF Monoclonal Antibody PBP1510 in Patients with Pancreatic Cancer

Eligibility Criteria

• 1. Patients who have known brain metastases will be excluded from the study. However, a patient may be included in the study, if has been previously treated for brain metastasis, the disease is well controlled for at least 3 months, and the patient is off steroids.
• 2. Patients who have undergone a major surgery within 4 weeks prior to the start of PBP1510 administration, other than endoscopic/radiation procedures, bypass surgery (i.e., gastrojejunostomy), laparoscopy, port placement or a diagnostic surgery (i.e., surgery done to obtain a diagnostic biopsy, without removal of an organ), as long as the patient has recovered from these minor surgical procedures.
• 3. Patients who have active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, e.g., an active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii (P. carinii), or other microorganisms that is under treatment with myelotoxic drugs.
• 4. Patient has a known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).
• 5. Patient has known history of or currently active hepatitis B (e.g., hepatitis B antigen \[HBsAg\] reactive), hepatitis C (e.g., HCV RNA \[qualitative\] is detected) or syphilis \[Venereal Disease Research Laboratory (VDRL) to detect antibodies in blood\]).
• 6. Patient has impaired cardiac function and uncontrolled cardiac diseases/hypertension that are deemed clinically significant by the Investigator and which could compromise the patient's safety or the study data integrity.
• 7. Patient has serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
• 8. Any other malignancy from which the patient has been disease-free for less than 5 years, except for adequately treated and cured basal or squamous cell skin cancer.
• 9. Patients who are enrolled in any other therapeutic clinical trial.
• 10. Patients currently receiving radiation therapy or those having received radiation within 4 weeks prior to study entry.
• 11. Patients having received investigational anti-cancer drug within 28 days (or 5 half-lives, whichever is longer) preceding the first dose of PBP1510 or chemotherapy within the last 4 weeks prior to the first dose of PBP1510.
• 12. Patients with known allergy or hypersensitivity to components of the PBP1510 formulation including the excipients and history of hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
• 13. Patients who are pregnant, or breast feeding.
• 14. Patients who are unwilling or unable to comply with study procedures.
• 15. Patients who are not eligible to participate in this study, as judged by Investigators.
• 16. A history of allergic reactions attributed to gemcitabine or compounds of similar chemical composition to gemcitabine and/or previous treatment discontinuation due to gemcitabine toxicity.