FF-10850 Topotecan Liposome Injection for Advanced Solid Tumors

A Phase 1 Study of FF-10850 Topotecan Liposome Injection in Advanced Solid Tumors Including Ovarian and Cervical Carcinoma, Sarcomas, and Neuroendocrine Tumors Including Small Cell Lung Cancer and Merkel Cell Carcinoma

This study is testing a new injection called FF-10850 to see if it can safely help people with advanced solid tumors, like Merkel cell carcinoma.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 8 sites (Scottsdale, Arizona and 7 other locations)
• Trial ID: NCT04047251 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of FF-10850, a topotecan liposome injection, in patients with advanced solid tumors, including Merkel cell carcinoma. The study consists of a dose-escalation phase to determine the maximum tolerated dose and recommended Phase 2 dose, followed by an expansion phase for specific cancer cohorts. Patients will receive the treatment intravenously until disease progression or unacceptable adverse effects occur. The trial aims to enroll approximately 96 patients across multiple centers over a period of three years.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with metastatic or unresectable solid tumors that have relapsed or are refractory to standard treatments.

Not a fit: Patients with solid tumors for which effective standard therapies are available or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are resistant to standard therapies.

How similar studies have performed: While this approach is novel in its specific application, similar studies using liposomal formulations of chemotherapy have shown promise in treating various cancers.

Eligibility criteria

Inclusion Criteria:

Patients must meet all the following criteria to participate in the study:

1. Males and females ≥ 18 years of age
2. Dose-escalation phase: Histologically or cytologically confirmed metastatic and/or unresectable 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 3 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-10850
4. Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 1
5. Life expectancy of ≥ 3 months
6. Adequate hematologic parameters without ongoing transfusion support:

   * Hemoglobin (Hb) ≥ 9 g/dL
   * Absolute neutrophil count (ANC) ≥ 1.0 × 109 cells/L
   * Platelets ≥ 100 × 109 cells/L
7. Creatinine ≤ 1.5 × ULN, or calculated creatinine clearance ≥ 50 mL/minute by either the Cockcroft-Gault formula or as measured by a 24-hour urine collection
8. Total bilirubin ≤ 2 × ULN unless due to Gilbert's disease; patients with Gilbert's disease who have a total bilirubin \> 6 mg/dL are to be excluded
9. ALT and AST ≤ 2.5 times ULN, or \< 5 × ULN for patients with liver metastases
10. QT interval corrected for rate (QT interval corrected for rate using Fridericia's Correction Formula, QTcF) ≤ 470 msec for women and ≤ 450 msec for men on the ECG obtained at Screening and confirmed pre-treatment on Cycle 1 Day 1.
11. Patient must be willing to undergo a tumor biopsy, if the patient has a biopsy-accessible tumor

Exclusion Criteria:

1. Patients who have not received standard/approved therapies expected to improve survival by at least 3 months
2. History of severe hypersensitivity reactions to topotecan
3. Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV or hereditary long QT syndrome
4. Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, except for antimicrobials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care
5. Active central nervous system (CNS) malignant disease in patients with a history of CNS malignancy. Patients with previously treated stable brain metastases are allowed if they have been stable off steroid therapy for at least 4 weeks.
6. 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

Where this trial is running

Scottsdale, Arizona and 7 other locations

• HonorHealth — Scottsdale, Arizona, United States (Recruiting)
• Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States (Recruiting)
• Dana Farber Cancer Institute (DFCI) — Boston, Massachusetts, United States (Active_not_recruiting)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (Completed)
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Recruiting)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (Withdrawn)
• MD Anderson Cancer Center — Houston, Texas, United States (Completed)
• University of Wisconsin Clinical Science Center — Madison, Wisconsin, United States (Recruiting)

Study contacts

• Study coordinator: FPHU Study Coordinator

Conditions Advanced Solid Tumors; Merkel Cell Carcinoma