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Clinical Trials in the USA / NCT05318573
Active, not recruiting Phase 2

A Study to Evaluate Safety, Efficacy of FF-10832 in Combo With Pembrolizumab in Urothelial & Non-small Cell Lung Cancer

NCT05318573 · tracked via the Priya Life Science USA tracker
Sponsor
Fujifilm Pharmaceuticals U.S.A., Inc.
Phase
Phase 2
Started
2022-06-01
Last updated
2025-09-04

Condition(s) studied

Advanced Urothelial CarcinomaAdvanced Non Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

PembrolizumabFF-10832

Pembrolizumab: Treatment at 200 mg pembrolizumab, administered intravenously (IV) on Day 1 of each 21-day cycle prior to infusion of FF-10832

FF-10832: Following administration of pembrolizumab, FF-10832 Gemcitabine Liposome Injection, 40 mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (23)

FacilityCityRegionStatus
Cancer and Blood Speciality Clinic Long Beach California
Sharp Memorial Hospital (Oncology Clinical Research) San Diego California
Sibley Memorial Hospital Washington D.C. District of Columbia
University of Kansas Cancer Center - Westwood Westwood Kansas
University of Kentucky Medical Center Lexington Kentucky
University of Louisville Brown Cancer Center Louisville Kentucky
Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion) Detroit Michigan
Washington University School of Medicine, Center for Adv Medicine St Louis Missouri
Nebraska Cancer Specialists - Legacy Omaha Nebraska
Comprehensive Cancer Centers of Nevada - Southern Hills Las Vegas Nevada
Atlantic Health System / Morristown Medical Center Morristown New Jersey
NYU Langone Health New York New York
Icahn School of Medicine at Mount Sinai New York New York
TriHealth Cancer Institute; Good Samaritan Hospital Cincinnati Ohio
Providence Cancer Institute Franz Clinic Portland Oregon
Hospital of the Univ of Pennsylvania Perlman Center Philadelphia Pennsylvania
UPMC Hillman Cancer Center Pittsburgh Pennsylvania
Medical University of South Carolina Charleston South Carolina
Avera Cancer Institute Sioux Falls South Dakota
Sarah Cannon Research Institute Nashville Tennessee
University of Texas Southwestern Medical Center Dallas Texas
Virginia Cancer Specialists, PC Fairfax Virginia
University of Wisconsin Clinical Science Center Madison Wisconsin

On this site

📄 Keytruda (pembrolizumab) drug profile →

More Fujifilm Pharmaceuticals U.S.A., Inc. trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05318573 on ClinicalTrials.gov ↗ ← All trials in the USA