A Phase 1 Dose-escalation Study of FF-10832 Monotherapy or in Combination With Nab-paclitaxel for the Treatment of Advanced Solid Tumors
Brief SummaryTo determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT) and recommended Phase 2 dose (RP2D) in patients who receive FF-10832 (Gemcitabine Liposome Injection) for treatment of advanced solid tumors.
Detailed DescriptionDose-escalation Phase Eligible patients will receive FF-10832 in 28 day cycles. Dosing will continue 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. Expansion Phase Once 6 patients are treated at the MTD or RP2D in each regimen during the dose-escalation phase, it is anticipated that up to three additional cohorts, distributed among the regimens, may enroll up to 12 patients each.
Inclusion and Exclusion Criteria
- Males and females ≥ 18 years of age
- 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
- 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
- Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 1
- Life expectancy of ≥ 3 months
- Ability to provide written informed consent
- Patients who have not received standard/approved therapies expected to improve survival by at least 3 months
- Prior hypersensitivity to gemcitabine
- Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV)
- Active infection requiring intravenous (IV) antibiotic usage within the last week prior to study treatment
- 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
- Pregnant or breast-feeding
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