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.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05318573

Provider View

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

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.

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