A Study to Evaluate Safety, Efficacy of FF-10832 in Combo With Pembrolizumab in Urothelial & Non-small Cell Lung Cancer
To confirm a recommended Phase 2 dose (RP2D) of FF-10832 (Gemcitabine Liposome Injection) given intravenously Day 1 of a 21-day cycle, in combination with 200 mg pembrolizumab given intravenously Day 1 of the same 21-day cycle, for treatment of advanced urothelial and non-small cell lung cancer
Checked against the public recordLast updated Sep 4, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Fujifilm Pharmaceuticals U.S.A., Inc.
- Interventions being studied
- Drug: Pembrolizumab; Drug: FF-10832
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: 1. Written informed consent is provided by patient or legally acceptable representative; 2. Age ≥ 18 years; 3. Patient populations: 1. In the Safety Run-in, patients with histologically or cytologically confirmed advanced or metastatic solid tumors who have disease progression after treatment with standard therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment or refuse standard treatment will be enrolled in therapy 2. In Expansion Phase, patient must have urothelial or NSCLC, and have failed prior anti-PD-1 or anti-PD-L1 4. Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology 5. Eastern Cooperative Oncology Group performance status of 0 to 1 6. Life expectancy of ≥ 3 months Exclusion Criteria: 1. Positive urine pregnancy test within 72 hours prior to treatment 2. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (or 5 half-lives, whichever is shorter) prior to treatment; 3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), AND was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event; 4. Has received prior radiotherapy within 2 weeks of start of study treatment. 5. For patients with NSCLC: 1. Patients who have received radiation therapy to the lung that is \>30 Gy within 6 months of the first dose of trial treatment are excluded; 2. Patients with mutations (e.g., EGFR mutations or ALK gene rearrangements) will be excluded unless they have been previously treated with all specific targeted therapies. 6. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. 7. Has had an allogeneic tissue /solid organ transplant.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Cancer and Blood Speciality ClinicLong Beach, California
- Sharp Memorial Hospital (Oncology Clinical Research)San Diego, California
- Sibley Memorial HospitalWashington D.C., District of Columbia
- University of Kansas Cancer Center - WestwoodWestwood, Kansas
- University of Kentucky Medical CenterLexington, Kentucky
- University of Louisville Brown Cancer CenterLouisville, Kentucky
- Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)Detroit, Michigan
- Washington University School of Medicine, Center for Adv MedicineSt Louis, Missouri
- Nebraska Cancer Specialists - LegacyOmaha, Nebraska
- Comprehensive Cancer Centers of Nevada - Southern HillsLas Vegas, Nevada
- Atlantic Health System / Morristown Medical CenterMorristown, New Jersey
- NYU Langone HealthNew York, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 4, 2025. Always confirm current availability with the study team.