FID-007 in Treating Participants With Advanced Solid Tumors

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) of FID-007 and the recommended phase II dose
(RP2D).

II. To determine the pharmacokinetics of paclitaxel, (free and total) in patients treated
with FID-007.

SECONDARY OBJECTIVES:

I. To characterize the safety and tolerability of FID-007 by assessing toxicities per Common
Terminology Criteria for Adverse Events (CTCAE) version (v.)4.3.

II. To obtain a preliminary assessment of anti-tumor activity of FID-007 via objective
radiologic tumor response using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

EXPLORATORY OBJECTIVES:

I. To evaluate in a preliminary fashion the serum concentration of total paclitaxel and free
paclitaxel, and explore potential associations with serum concentrations, efficacy and
toxicity.

OUTLINE: This is a dose escalation study.

Participants receive FID-007 intravenously (IV) over 60 minutes on days 1, 8 and 15. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up periodically.

Inclusion Criteria:

- Patients must have histopathologically /cytologically confirmed advanced solid tumor
which is refractory to standard therapeutic options, or for which there are no
standard therapeutic options, or for whom paclitaxel is an appropriate palliative
treatment option (patients for whom paclitaxel or nab-paclitaxel are established
treatment options with a proven survival benefit in first line will be excluded)

- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status ? 2

- Patient must have recovered from any toxic effects of previous chemotherapy, targeted
therapy or radiotherapy as judged by the investigator to ? grade 1

- Previous chemotherapy/radiotherapy/targeted therapy should have been completed at
least 4 weeks prior to start of FID-007 administration

- Patients must have an estimated life expectancy of at least 3 months

- Female patients of child bearing potential must have negative serum pregnancy test at
screening

- Sexually active women, unless surgically sterile (at least 6 months prior to study
drug administration) or postmenopausal for at least 12 consecutive months, must use an
effective method of avoiding pregnancy (including oral, transdermal, or implanted
contraceptives [any hormonal method in conjunction with a secondary method],
intrauterine device, female condom with spermicide, diaphragm with spermicide,
absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile
[at least 6 months prior to study drug administration] sexual partner) for at least 4
weeks prior to study drug administration, during study and up to 30 days or till next
chemotherapy cycle; cessation of birth control after this point should be discussed
with a responsible physician; investigator will discuss with patient on the above
points and the patient agreement will be documented in the source document; the
investigator should ensure that the patient is using an effective method of avoiding
pregnancy as per protocol; in case of male patients: either patient partners or
patients themselves must use an effective method of avoiding pregnancy for at least 4
weeks prior to study drug administration, during study and up to 30 days or till next
chemotherapy cycle

- Patients must agree, as part of the informed consent, to provide blood for
pharmacokinetics analysis

- Absolute neutrophil count (ANC) ? 1500/mm^3

- Platelet count ? 100,000/mm^3

- Hemoglobin ? 8 g/dL

- Serum creatinine ? 1.5 X upper limit of normal (ULN) OR calculated clearance ? 50
mL/min/1.73 m^2; if using creatinine clearance, actual body weight should be used for
calculating creatinine clearance (e.g., using the Cockcroft-Gault formula); for
subjects with a body mass index (BMI) > 30 kg/m^2, lean body weight should be used
instead

- Total bilirubin ? 1 X ULN (subjects with Gilbert?s disease can have bilirubin of up to
1.5 X ULN)

- Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) < 3 X ULN

- Patients in the dose escalation phase of the study must have measurable or evaluable
disease according to RECIST 1.1 criteria

Exclusion Criteria:

- Patients who have had hypersensitivity to paclitaxel or any of its excipients

- Patients must not have received more than 3 prior lines of cytotoxic chemotherapy for
advanced disease; treatment with targeted agents or biologic agents such as antibodies
as single agents will not count as a line of cytotoxic chemotherapy

- Patient must not have had prior treatment with paclitaxel or nab-paclitaxel

- Patients must not have serious medical risk factors involving any of the major organ
systems, or serious psychiatric disorders, which could compromise the subject's safety
or the study data integrity; these include, but are not limited to: history of
interstitial lung disease, slowly progressive dyspnea and unproductive cough,
sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity
pneumonitis or multiple allergies

- Patient must not have a history of the following within 6 months prior to cycle 1 day
1: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral
artery bypass graft, New York Heart Association (NYHA) class III-IV heart failure,
uncontrolled hypertension, clinically significant cardiac dysrhythmia or
electrocardiogram (ECG) abnormality, cerebrovascular accident, transient ischemic
attack, or seizure disorder

- Patients who have pre-existing motor or sensory neuropathy of a severity ? grade 1 by
CTCAE v4.0 criteria

- Patients who have known active hepatitis B or C

- Patients who have active infection including known human immunodeficiency virus (HIV)
infection

- Patients who have concurrent conditions resulting in immune compromise, including
chronic treatment with corticosteroids or other immunosuppressive agents

- Patients who are on therapeutic anticoagulation with warfarin; patients on therapeutic
doses of with low molecular weight heparins are eligible

- Patients who have ongoing cardiac dysrhythmias, atrial fibrillation, or prolongation
of corrected QTc interval to > 480 msec on 2 out of 3 electrocardiograms (EKGs) (if
first EKG has QTc < 480, no need to repeat, if first EKG has QTc > 480 repeat twice
for a total of 3 EKGs)

- Patients who have known brain metastasis; patients whose central nervous system (CNS)
metastases have been treated by surgery or radiotherapy, who are no longer on
corticosteroids, and who are neurologically stable are eligible

- Patients for whom paclitaxel (or nab-paclitaxel) is being used in the curative
setting, either adjuvant or neoadjuvant, and patients who would receive paclitaxel (or
nab-paclitaxel) as first line therapy in a tumor type in which paclitaxel (or
nab-paclitaxel) has a proven survival benefit for metastatic disease