A Multi-Center, Phase 2, Open Label Study of Safety and Efficacy of Oral Recombinant Human Lactoferrin (rhLF) Monotherapy in Patients With Advanced Renal Cell Carcinoma (RCC), Who Have Failed at Least One Regimen of Systemic Therapy for RCC

Inclusion Criteria:

- Age ≥18 years

- Histologically confirmed, advanced or metastatic RCC with predominantly clear cell
histology that is unresectable or medically inoperable.

- Experienced and failed at least one regimen of systemic therapy for RCC with CT
documentation of disease progression.

- A previous CT (4 weeks or more prior to the Screening CT) showing progression of the
target tumor(s) compared to a prior CT no more than 9 months previously

- At least one target tumor lesion is measurable at Screening with CT scan, according
to RECIST, and not previously irradiated

- Karnofsky performance status of ≥70 (ECOG <2)

- Able to understand and sign an informed consent

Exclusion Criteria:

- Significant sarcomatoid, spindle cell, or nuclear grade 4 histology

- Significant non-clear cell RCC (for example, papillary, chromophobe, collecting duct,
granular, or unclassified RCC)

- Total bilirubin >1.5 mg/dL

- Serum creatinine >2.0 mg/dL

- Hemoglobin <10.0 g/dL

- Absolute neutrophil count <2000/mm3

- Lymphocytes <800/mm3

- Platelet count <100,000/mm3

- AST (SGOT) or ALT (SGPT) ≥2.5 x institutional upper limit of normal

- Serum calcium >11.5 mg/dl

- International Normalized Ratio of Prothrombin Time (INR) >1.2

- FEV1 <60% predicted or FVC <60% predicted by spirometry (both are to be measured)

- Existing or history of brain metastases

- History of allergic reactions to compounds of similar chemical or biologic
composition to the Study Agent rhLF

- Active ischemic heart disease, symptomatic congestive heart failure

- Serious active infection

- Psychiatric illness/social situations that would limit compliance with study
requirements

- Autoimmune diseases (e.g., systemic lupus erythematosus, multiple sclerosis or
ankylosing spondylitis)

- Other malignancies, except non-melanoma skin cancer, within 5 years of study entry

- Radiotherapy within 4 weeks prior to study treatment start

- Corticosteroid therapy within 4 weeks prior to treatment start, with the exception of
inhaled or topical steroids

- Chemotherapy/Immunotherapy (e.g., IL-2, INFα, tumor vaccine) within 4 weeks prior to
study treatment start

- Known HIV positive

- Receipt of any investigational medication within 30 days prior to participation in
the study

- Pregnant or lactating patients, or fertile female patients with a positive pregnancy
test (serum β-human chorionic gonadotropin [β-HCG] at Screening and on Day 1 prior to
the first dose), or fertile female patients unwilling to use adequate contraception
prior to study entry, during treatment and 30 days after completion of treatment

- Sexually active male patients unwilling to practice contraception while participating
on this study and up to 30 days after completion of treatment

- Unable to take liquid medication by mouth or feeding tube