Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors

The study will initially employ an accelerated escalation design, with a single patient
enrolled in each cohort (i.e., Single-Patient Cohorts). The initial patient will receive
CPX-POM at a starting dose of 30 mg/m2. Doses will be escalated (doubling), until a ≥Grade 2
toxicity (with the exception of alopecia), is encountered. Subsequently that and all
subsequent cohorts will follow a classical "3 + 3" dose escalation design.

Inclusion Criteria Include:

1. Patient has histologically- or cytologically- confirmed metastatic or advanced-stage
solid malignant tumor that is refractory to standard therapy. Patients should only be
included if no therapy exists or if they have already received all standard therapies
that would be potentially curative or might provide significant benefit.

2. Patient may have received up to 4 prior lines of cytotoxic chemotherapy or
immunotherapy for their metastatic disease (e.g., docetaxel + doxorubicin ±
cyclophosphamide), and also may have received additional prior endocrine therapy, as
appropriate (e.g., for breast or prostate cancer), or non-myelosuppressive therapy
(e.g., bevacizumab, trastuzumab).

3. Patient has experienced progressive disease during or following or was intolerant of
their most recent treatment regimen. Supporting information about prior progressive
disease will be collected, if available.

4. Patient is male or female aged ≥18 years.

5. Patient provided signed and dated informed consent prior to initiation of any study
procedures.

6. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0
(fully active, able to carry out all pre-disease activities without restriction) or 1
(unable to perform physically strenuous activity but ambulatory and able to carry out
work of a light or sedentary nature), as assessed on Composite International
Diagnostic Interview (CIDI), before the first dose of CPX-POM.

7. Patient has adequate renal function (creatinine ≤1.5 × the upper limit of normal
[ULN]) or a glomerular filtration rate (GFR) of ≥50 mL/min).

8. Patient has adequate hepatic function, as evidenced by a total bilirubin ≤1.5 × ULN,
aspartate transaminase (AST), and /or alanine transaminase (ALT) ≤3 × ULN or ≤5 ×ULN,
if due to liver involvement by tumor.

9. Patient has adequate bone marrow function, as evidenced by hemoglobin ≥9.0 g/dL in the
absence of transfusion within the previous 72 hours, platelet count ≥100×109cells/L,
and absolute neutrophil count (ANC) ≥1.5×109 cells/L.

10. Patient has no significant ischemic heart disease or myocardial infarction (MI) within
6 months before the first dose of CPX-POM. The eligibility of patients with
ventricular pacemakers for whom the QT interval may not be accurately measurable will
be determined on a case-by-case basis by the Sponsor in consultation with the Medical
Monitor.

11. Patient and his/her partner agree to use adequate contraception after providing
written informed consent through 3 months after the last dose of CPX-POM, as follows:

1. For women: Negative pregnancy test during Screening and at CIDI and compliant
with a medically-approved contraceptive regimen during and for 3 months after the
treatment period or documented to be surgically sterile or postmenopausal.

2. For men: Compliant with a medically-approved contraceptive regimen during and for
3 months after the treatment period or documented to be surgically sterile. Men
whose sexual partners are of child-bearing potential must agree to use 2 methods
of contraception prior to study entry, during the study, and for 3 months after
the treatment period.

12. Patient is willing and able to participate in the study and comply with all study
requirements.

Exclusion Criteria Include:

Patients who meet any of the following exclusion criteria are not to be enrolled in this
study

1. Patient has a history of risk factors for torsade de pointes (e.g., heart failure,
hypokalemia, family history of long QT syndrome) or requires the use of concomitant
medications that prolong the QT/QTc interval during study participation (refer to the
following for examples: http://www.azcert.org/medical-pros/drug-lists/drug-lists.cfm).

2. Patient has an abnormal cardiac appearance/heart size, as evidenced by chest X-ray or
computed tomography (CT) scan.

3. Patient has an uncontrolled or severe intercurrent medical condition.

4. Patient underwent major surgery within 4 weeks before the first dose of CPX-POM or
received cancer-directed therapy (chemotherapy, radiotherapy, hormonal therapy,
biologic or immunotherapy, etc.) or an investigational drug or device within 4 weeks
(6 weeks for mitomycin C and nitrosoureas) or 5 half-lives of that agent (whichever is
shorter) before the first dose of CPX-POM. A minimum of 10 days between termination of
the investigational drug and administration of CPX-POM is required. In addition, any
drug-related toxicity, with the exception of alopecia, should have recovered to ≤Grade
1.

5. If female, patient is pregnant or breast-feeding.

6. Patient has evidence of a serious active infection (e.g., infection requiring
treatment with intravenous antibiotics).

7. Patient has an important medical illness or abnormal laboratory finding that, in the
Investigator's opinion, would increase the risk of participating in this study.

8. Patient is taking warfarin.

9. Patient has a history of other malignancy treated with curative intent within the
previous 5 years with the exception of adequately treated non-melanoma skin cancer or
carcinoma in situ of the cervix. Subjects with previous invasive cancers are eligible
if the treatment was completed more than 5 years prior to initiating current study
treatment, and there is no evidence of recurrent disease.