A Study to Test the Effectiveness of ABI-009 in Patients With Metastatic, Unresectable, Low or Intermediate Grade Neuroendocrine Tumors of the Lung or Gastroenteropancreatic System

ABI-009, human albumin-bound rapamycin, is an experimental drug. "Experimental" means that
the drug has not been approved by the Food and Drug Administration (FDA).

Rapamycin, the active part of the drug, inhibits a biological pathway (mTOR) that certain
cancers use to grow. Rapamycin and similar types of drugs have been used in many other
tumors, including advanced renal cell carcinoma. A standard mTOR inhibitor used in
neuroendocrine tumors is everolimus. The human albumin component of ABI-009 may allow
rapamycin to reach cancer cells more effectively.

ABI-009 has not been approved for the treatment of advanced, malignant neuroendocrine tumors
of the lung, gastrointestinal tract and/or pancreas. The information from this study might
help us identify if ABI-009 is safe and effective in this disease.

Inclusion Criteria:

1. Unresectable or metastatic patients with typical or atypical carcinoid tumors of the
lung or low or intermediate grade gastroenteropancreatic neuroendocrine tumors
(GEPNETs).

2. Patients must have measurable disease per RECIST 1.1.

3. Patients must have progressed on everolimus or been intolerant to everolimus.

4. Patients, ≥18 years old, must have Eastern Cooperative Oncology Group (ECOG)
Performance Status 0 or 1.

5. Concurrent use of somatostatin analogs (SSAs) is allowed if currently used for symptom
control.

6. Adequate liver function:

1. Total bilirubin ≤1.5 x upper limit of normal (ULN) mg/dL

2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN
(<5 x ULN if the patient has liver metastases).

7. Adequate renal function:

a. Serum creatinine ≤2 x ULN or creatinine clearance >50 cc/hr (Cockroft-Gault).

8. Adequate biological parameters:

1. Absolute neutrophil count (ANC) ≥1.5 × 109/L

2. Platelet count ≥100,000/mm3 (100 × 109/L)

3. Hemoglobin ≥9 g/dL.

9. Fasting serum triglyceride ≤300 mg/dL; fasting serum cholesterol ≤350 mg/dL.

10. Male or non-pregnant and non-breast feeding female:

- Females of child-bearing potential must agree to use effective contraception
without interruption from 28 days prior to starting investigational product (IP)
throughout 3 months after last dose of IP and have a negative serum pregnancy
test (β-hCG) result at screening and agree to ongoing pregnancy testing during
the course of the study, and after the end of study treatment. A second form of
birth control is required even if she has had a tubal ligation.

- Male patients must practice abstinence or agree to use a condom during sexual
contact with a pregnant female or a female of childbearing potential while
participating in the study and throughout 3 months after last dose of IP. A
second form of birth control is required even if he has undergone a successful
vasectomy.

11. Life expectancy of >3 months, as determined by the investigator.

12. Ability to understand and sign informed consent.

13. Willingness and ability to comply with scheduled visits, laboratory tests, and other
study procedures.

Exclusion Criteria:

1. Patients currently undergoing anti-cancer therapy for neuroendocrine tumors (other
than SSAs for symptoms).

2. History of allergic reactions to compounds of similar chemical or biologic composition
to ABI-009.

3. Known active uncontrolled or symptomatic central nervous system (CNS) metastases. A
patient with controlled and asymptomatic CNS metastases may participate in this study.
As such, the patient must have completed any prior treatment for CNS metastases ?28
days (including radiotherapy and/or surgery) prior to start of treatment in this study
and should not be receiving chronic corticosteroid therapy for the CNS metastases.

4. Active gastrointestinal bleeding.

5. Uncontrolled serious medical or psychiatric illness. Patients with a "currently
active" second malignancy other than non-melanoma skin cancers, carcinoma in situ of
the cervix, resected incidental prostate cancer (staged pathological tumor-2 (pT2)
with Gleason Score ≤6 and postoperative prostate-specific antigen (PSA) <0.5 ng/mL),
or other adequately treated carcinoma-in-situ are ineligible. Patients are not
considered to have a "currently active" malignancy if they have completed therapy and
are free of disease for ≥1 year).

6. Recent infection requiring systemic anti-infective treatment that was completed ≤14
days prior to enrollment (with the exception of uncomplicated urinary tract infection
or upper respiratory tract infection).

7. Uncontrolled diabetes mellitus as defined by HbA1c >8% despite adequate therapy.

8. Unstable coronary artery disease or myocardial infarction during preceding 6 months.

9. Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary
hypertension.

10. Use of strong inhibitors and inducers of CYP3A4 within the 14 days prior to receiving
the first dose of ABI-009. Additionally, use of any known CYP3A4 substrates with
narrow therapeutic window (such as fentanyl, alfentanil, astemizole, cisapride,
dihydroergotamine, pimozide, quinidine, terfanide) within the 14 days prior to
receiving the first dose of ABI-009.

11. Known Human Immunodeficiency Virus (HIV).

12. Known active Hepatitis B or Hepatitis C.