FF-10850 Topotecan Liposome Injection for Advanced Solid Tumors
Official title: 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
Run by Fujifilm Pharmaceuticals U.S.A., Inc. · NCT04047251 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 96 (estimated) |
| 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 |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is novel in its specific application, similar studies using liposomal formulations of chemotherapy have shown promise in treating various cancers.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
HonorHealth
Scottsdale, Arizona, United States Recruiting -
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States Recruiting -
Ohio State University Wexner Medical Center
Columbus, Ohio, United States Recruiting -
University of Wisconsin Clinical Science Center
Madison, Wisconsin, 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
Show 2 more locations
-
University of Texas Southwestern Medical Center
Dallas, Texas, United States Withdrawn -
MD Anderson Cancer Center
Houston, Texas, United States Completed
Study contacts
- Study coordinator: FPHU Study Coordinator
- Email: fphu@td2inc.com
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ABBV-253 in adults with advanced solid tumors
This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.
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MK-2010 alone or with other treatments for advanced solid tumors
This trial tests MK-2010, by itself or with other cancer medicines, to see if it helps people with advanced solid tumors.
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Whole-Body Infrared Heating for Advanced Solid Tumors
This study looks at how ET-SPACE whole-body infrared hyperthermia affects people with advanced solid tumors to see if it changes biology, symptoms, and safety.
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MK-2010 with Sac-TMT in advanced solid tumors
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.