Study on the Safety and Effectiveness of FF-10832 with Pembrolizumab for Urothelial and Non-Small Cell Lung Cancer
Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc.
ClinicalTrials ID:NCT05318573
This clinical trial is testing a new treatment combination of FF-10832 and pembrolizumab to find the best dose and see how well it works for patients with advanced urothelial and non-small cell lung cancer.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to determine the best dose of FF-10832, a form of gemcitabine given through an IV, when used with pembrolizumab, another IV medication, for treating advanced urothelial and non-small cell lung cancer. The treatment is given on the first day of a 21-day cycle.
Description
This is a Phase 2a clinical trial where patients will receive FF-10832 in combination with pembrolizumab or as a standalone treatment. Initially, 10 patients will receive both drugs to ensure safety. FF-10832 will be given at a dose of 40 mg/m2, and pembrolizumab at a fixed dose of 200 mg.
Once the safe dose is confirmed, the trial will expand to include up to 100 more patients divided into two groups: those with urothelial cancer (UC) and those with non-small cell lung cancer (NSCLC). Each group will have two treatment options: either FF-10832 alone or combined with pembrolizumab. This will help determine the safety and effectiveness of FF-10832 alone or with pembrolizumab in these cancers.
Patients in the UC and NSCLC groups must have previously tried PD-1/PD-L1 therapies without success. The study will help gather information on how well the treatment works against tumors.
Eligibility Criteria
Inclusion Criteria
- Must provide written informed consent.
- Must be 18 years or older.
- For the initial safety phase, patients must have advanced or metastatic solid tumors that have worsened after standard treatments or cannot tolerate or refuse standard treatments.
- For the expansion phase, patients must have urothelial cancer or NSCLC and have not responded to previous anti-PD-1 or anti-PD-L1 treatments.
- Must have measurable disease as determined by specific medical criteria.
- Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Must have a life expectancy of at least 3 months.
Exclusion Criteria
- Positive pregnancy test within 72 hours before treatment.
- Have received any anti-cancer treatment, including experimental drugs, within 4 weeks before starting the study.
- Have had severe side effects from previous treatments targeting PD-1, PD-L1, or similar receptors.
- Have received radiation therapy within 2 weeks before starting the study.
- For NSCLC patients:
- Have had lung radiation therapy over 30 Gy within 6 months before starting the study.
- Have specific genetic mutations unless previously treated with targeted therapies.
- Have received a live vaccine within 30 days before starting the study.
- Have had a tissue or organ transplant.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Sharp Memorial Hospital (Oncology Clinical Research) | 92123 | San Diego | California |
| Sibley Memorial Hospital | 20016 | Washington | District of Columbia |
| University of Kansas Cancer Center - Westwood | 66205 | Westwood | Kansas |
| University of Kentucky Medical Center | 40536 | Lexington | Kentucky |
| University of Louisville Brown Cancer Center | 40202 | Louisville | Kentucky |
| Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion) | 48202 | Detroit | Michigan |
| Washington University School of Medicine, Center for Adv Medicine | 63110 | Saint Louis | Missouri |
| Comprehensive Cancer Centers of Nevada - Southern Hills | 89148 | Las Vegas | Nevada |
| Atlantic Health System / Morristown Medical Center | 07960 | Morristown | New Jersey |
| NYU Langone Health | 10016 | New York | New York |
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