A Phase 1 Dose-escalation Study of FF 10832 for the Treatment of Advanced Solid Tumors

Dose-escalation Phase Eligible patients will receive FF-10832. In the first cohort, FF-10832
1.2 mg/mPP2PP will be administered intravenously (IV) on Days 1 and 15 of each 28-day cycle,
until progression of disease, observation of unacceptable adverse events, intercurrent
illness, or changes in the patient's condition that prevents further study participation
after discussion between the Investigator and the Medical Monitor. A number of cohorts will
be enrolled sufficient to determine the MTD and to identify the RP2D.

Inclusion Criteria:

1. Males and females ≥ 18 years of age

2. Histologically or cytologically confirmed metastatic solid tumor, relapsed or
refractory to standard therapy, or for which no standard therapy is available that is
expected to improve survival by at least three months

3. At least 3 weeks beyond the last chemotherapy (or 3 half-lives, whichever is shorter),
radiotherapy, major surgery, or experimental treatment, and recovered from all acute
toxicities (≤ Grade 1), prior to the first dose of FF-10832

5. Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 1

6. Life expectancy of ≥ 3 months

7. Ability to provide written informed consent

Exclusion Criteria:

1. Patients who have not received standard/approved therapies expected to improve
survival by at least 3 months

2. Prior hypersensitivity to gemcitabine

3. Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface
antigen (HBsAg) or hepatitis C virus (HCV)

7. Active infection requiring intravenous (IV) antibiotic usage within the last week prior
to study treatment

8. Any other medical intervention or other condition which, in the opinion of the Principal
Investigator, could compromise adherence to study requirements or confound the
interpretation of study results

9. Pregnant or breast-feeding