This is an open-label phase 1A/1B study to assess the safety, tolerability and
pharmacokinetics of SBP-101 when combined with nab-paclitaxel and gemcitabine in subjects
with previously untreated metastatic pancreatic ductal adenocarcinoma and to identify a
recommended phase 2 dose. The study will also assess preliminary efficacy of the 3-drug
The study will be conducted in two phases: dose escalation and expansion. Up to three dose
levels of SBP-101 will be assessed in up to 18 subjects during dose escalation. The expansion
phase of the study will consist of 10 additional subjects who will receive the recommended
dose of SBP-101 combined with nab-paclitaxel and gemcitabine.
- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
Patients with pancreatic acinar cell carcinoma may also be included.
- Is previously untreated for metastatic pancreatic ductal adenocarcinoma, was diagnosed
within the past 3 months, and is expected to receive standard treatment with
gemcitabine and nab-paclitaxel.
- Measurable disease on CT or MRI scan by RECIST v 1.1 criteria.
- ECOG Performance Status 0 or 1.
- Adult, age ≥ 18 years, 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. Female subjects will be considered to be of
childbearing potential unless they are postmenopausal (at least 12 months of
consecutive amenorrhea, without other known or suspected cause) and over 55 years old
or have been sterilized surgically (i.e., bilateral tubal ligation, hysterectomy or
bilateral oophorectomy, all with surgery at least one month before dosing).
- Adequate bone marrow, hepatic, renal and coagulation function as defined by the
1. Absolute neutrophil count ≥1.5 x 109/L
2. Hemoglobin ≥9.0 g/dL (90 g/L)
3. Platelets ≥100 x 109/L
4. 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.
5. Bilirubin ≤1.5 x ULN
6. Prothrombin time (PT) / international normalized ratio (INR) ≤1.5 x ULN if not on
7. Calculated creatinine clearance >50 mL/min using the Cockcroft and Gault equation
- QTc interval ≤ 470 msec at Baseline.
- Life expectancy ≥ 3 months.
- 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.
- 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
- 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)
- Evidence of deep vein thrombosis or pulmonary embolism or other thromboembolic event
- Presence of known active bacterial, fungal, or viral infection requiring systemic
- Known active infection with human immunodeficiency virus (HIV), hepatitis B or C
- Presence of interstitial lung disease, pulmonary fibrosis, or pulmonary
- 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.
- Pregnant or lactating
- Major surgery within 4 weeks of the start of study treatment, without complete
- Known hypersensitivity to any component of study treatments
- Participation in any other clinical investigation within 4 weeks of receiving the
first dose of study drug
- Subjects taking metformin. Diabetics on treatment with metformin, or any other
derivative thereof, must discontinue it while on study. (Other diabetic medications