Study of SBP-101 in Pancreatic Cancer

A Phase 1A/1B Study of SBP-101 in Previously Treated Subjects With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma

This phase 1 first-in-human study evaluates safety and tolerability of SBP-101 in subjects with previously treated pancreatic ductal adenocarcinoma and will identify the maximum tolerated dose (MTD). In addition, this study will also assess the pharmacokinetic (PK) profile and preliminary efficacy of SBP-101.

This first-in-human study of SBP-101 will be conducted in two phases: dose escalation and expansion. The dose escalation phase of the study is to evaluate the safety, tolerability and PK profile of SBP-101 in subjects with previously treated locally advanced or metastatic pancreatic ductal adenocarcinoma. Up to 48 subjects may be enrolled in dose escalation. The expansion phase of the study will consist of 24 additional subjects who will receive the maximum tolerated dose of SBP-101 based on data from the dose escalation phase of the study.

Inclusion Criteria:

• Histologically or cytologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma. Patients with acinar cell carcinoma may also be included.
• Measurable disease on CT or MRI scan by RECIST criteria (required for Phase 1b only).
• ECOG Performance Status 0 or 1.
• Received and failed, or were intolerant to, at least 1 prior systemic therapy for locally advanced or metastatic pancreatic ductal adenocarcinoma.
• Adult, at least 18 years of age, male or female
• Females of child-bearing potential must have a negative serum pregnancy test within 14 days prior to start of study treatment and must use an adequate method of contraception during the study. All sexually active males must also use an adequate method of contraception during the study.
• Adequate bone marrow, hepatic, renal and coagulation function as defined by the following: Absolute neutrophil count ≥1.5 x 10^9/L, Hemoglobin ≥9.0 g/dL (90 g/L), Platelets ≥100 x 10^9/L, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN) (if no hepatic metastases). If hepatic tumor involvement, AST and ALT ≤5 x ULN, Bilirubin ≤1.5 x ULN, Prothrombin time (PT) / international normalized ratio (INR) ≤1.5 x ULN, Calculated creatinine clearance >50 mL/min using the Cockcroft and Gault equation
• QTc interval ≤ 470 msec at Baseline
• Willing and able to provide written informed consent: voluntary agreement to participate in the study following disclosure of risks and procedures required, including possibility of onset of exocrine pancreatic insufficiency with subsequent requirement for life-long pancreatic enzyme replacement

Exclusion Criteria:

• Evidence of severe or uncontrolled systemic disease or any concurrent condition that, in the opinion of the Investigator or Medical Monitor, makes it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol. Subjects with pre-existing well-controlled diabetes are not excluded.
• Medical or psychiatric conditions that compromise the subject's ability to give informed consent or to complete the protocol or a history of non-compliance
• Presence of islet-cell or pancreatic neuroendocrine tumor or mixed adenocarcinoma-neuroendocrine carcinoma
• Have symptomatic central nervous system (CNS) malignancy or metastasis. Screening of asymptomatic subjects without history of CNS metastases is not required.
• Serum albumin <30 g/L (3.0 g/dL)
• Glycosylated hemoglobin (Hgb A1C) > 8.0%
• Life expectancy <16 weeks
• Presence of known active bacterial, fungal, or viral infection requiring systemic therapy
• Known infection with human immunodeficiency virus (HIV), hepatitis B or C
• Presence of interstitial lung disease, pulmonary fibrosis, or pulmonary hypersensitivity reaction
• Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure, New York Heart Association (NYHA) class III or IV
• Maldigestion/malabsorption syndrome pre-dating the diagnosis of pancreatic cancer.
• Known, existing coagulopathy or receiving anticoagulants
• Pregnant or lactating
• Major surgery within 4 weeks of the start of study treatment, without complete recovery
• Participation in any other clinical investigation within 4 weeks of receiving the first dose of study drug