Phase 1 Clinical Trial of Metastasis Inhibitor NP-G2-044 in Patients With Advanced or Metastatic Solid Tumors (Including Lymphoma)

Inclusion Criteria:

- Disease Related

- Patients must have documented history of histologically confirmed solid tumors
(as defined by ASCO/CAP guidelines) originating in breast, pancreas, prostate,
lung, colon, esophagus, liver, or ovary, and lymphomas, which are locally
advanced or metastatic and who are refractory or intolerant beyond primary
treatment for their malignancy, or for lymphoma patients who are not eligible for
or who have refused autologous or allogenic hematopoietic stem cell transplant

- Measurable or evaluable disease documented within one month of the planned
protocol treatment (Treatment Period Cycle 1, Day 1)first dose of study drug (PK
Period Day 1)

- ECOG performance score of 0 and 1

- Able to swallow capsules/tablets

Demographic • Male and females who are 18 years or older

Laboratory Values

- Hemoglobin ≥ 9.0 g/dL

- Absolute neutrophil count ≥ 1500/uL

- Platelet count ≥ 100,000/uL

- Serum creatinine ≤ 1.5 mg/dL or a 24-hour calculated estimated creatinine clearance of
≥ 60 mL/min

- Serum bilirubin ≤ 1.5 mg/dL

- Serum albumin ≥ 3g/dL

- AST (SGOT), ALP and ALT (SGPT) ≤ 2.5 times upper limit of normal (OR ≤ 5 times ULN in
the presence of known liver metastases)

- Prothrombin time (PT)/International Normalized Ratio (INR) and partial thromboplastin
time (PPT) ≤ 1.5 times the upper limit of normal

- Serum sodium, potassium, magnesium, calcium and phosphorous levels within
institutional normal limits; supplements required to maintain normal electrolyte
levels will be permitted

Ethical

• Before any study-specific procedure, the appropriate written informed consent must be
obtained

Exclusion Criteria:

Disease Related

- Clinical or radiographical evidence of active brain metastasis

- Patients who have not recovered to ≤ grade 1 toxicities except grade 2 alopecia or
neuropathy associated with previous chemotherapy, radiotherapy, biologic, hormone or
prior investigational therapies.

Medications:

- Chemotherapy or other cancer, radiation or surgical treatments within 2 weeks or five
half-lives (whichever is shorter) of the first dose of study drug (PK Period Day 1)
planned first protocol treatment (i.e., cycle 1 day 1) or not yet recovered from
respective treatments

- Patients who have had allogenic hematopoietic stem cell transplant or allogenic bone
marrow transplant

- Patients who have had prior solid organ transplant

- Patients who are on immune suppression drugs or anti-transplant rejection drugs

General:

- History of any medical or psychiatric condition or addictive disorder, or laboratory
abnormality that in the opinion of the investigator, may increase the risks associated
with study participation or treatments that may interfere with the conduct of the
study or the interpretation of study results

- Prior history of clinically significant gastrointestinal bleeding, intestinal
obstruction or gastrointestinal perforation within 6 months before planned initiation
of study treatment

- Uncontrolled diabetes

- History of long QT syndrome or clinically significant cardiac arrhythmia, other than
stable atrial fibrillation

- Mean QTcF > 450 msec in men and mean QTcF > 470 msec in women at screening

- Myocardial infarction within the previous 6 months before planned initiation of study
treatment

- Active infection requiring intravenous antibiotics within 2 weeks of the first dose of
study drug (PK Period Day 1) before planned initiation of study treatment

- Prior history or current positive tests for hepatitis B, hepatitis C or human
immunodeficiency virus

- Currently enrolled in or has not yet completed at least 30 days since ending other
investigational device or drug study before planned date of first dose, or the patient
is currently receiving other investigational agent(s)

- Pregnant, planning a pregnancy or breast feeding during the study

- Male or female not willing to use adequate contraceptive precautions during the study
period

- Unwilling or unable to comply with study requirements or not available for follow-up
assessments

- Any disorder that compromises the ability of the patient to give written informed
consent and/or to comply with study procedures.