A Study to Evaluate Safety, Efficacy of FF-10832 in Combo With Pembrolizumab in Urothelial & Non-small Cell Lung Cancer
Running, not enrolling · Phase 2
Conditions studied: Advanced Urothelial Carcinoma, Advanced Non Small Cell Lung Cancer
In brief
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
Key facts
- Study ID
- NCT05318573
- Run by
- Fujifilm Pharmaceuticals U.S.A., Inc.
- People needed
- 120
- Starts
- 2022-06-01
- Expected to finish
- 2029-11-01
- Last updated by the study team
- 2025-09-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Written informed consent is provided by patient or legally acceptable representative;
- Age ≥ 18 years;
- Patient populations:
- 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
- In Expansion Phase, patient must have urothelial or NSCLC, and have failed prior anti-PD-1 or anti-PD-L1
- Have measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
- Eastern Cooperative Oncology Group performance status of 0 to 1
- Life expectancy of ≥ 3 months
You may not qualify if…
- Positive urine pregnancy test within 72 hours prior to treatment
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (or 5 half-lives, whichever is shorter) prior to treatment;
- 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;
- Has received prior radiotherapy within 2 weeks of start of study treatment.
- For patients with NSCLC:
- 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;
- 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.
- Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
- Has had an allogeneic tissue /solid organ transplant.
Where it is running
- Cancer and Blood Speciality Clinic — Long Beach, California, United States
- Sharp Memorial Hospital (Oncology Clinical Research) — San Diego, California, United States
- Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
- University of Kansas Cancer Center - Westwood — Westwood, Kansas, United States
- University of Kentucky Medical Center — Lexington, Kentucky, United States
- University of Louisville Brown Cancer Center — Louisville, Kentucky, United States
- Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion) — Detroit, Michigan, United States
- Washington University School of Medicine, Center for Adv Medicine — St Louis, Missouri, United States
- Nebraska Cancer Specialists - Legacy — Omaha, Nebraska, United States
- Comprehensive Cancer Centers of Nevada - Southern Hills — Las Vegas, Nevada, United States
- Atlantic Health System / Morristown Medical Center — Morristown, New Jersey, United States
- NYU Langone Health — New York, New York, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- TriHealth Cancer Institute; Good Samaritan Hospital — Cincinnati, Ohio, United States
- Providence Cancer Institute Franz Clinic — Portland, Oregon, United States
- Hospital of the Univ of Pennsylvania Perlman Center — Philadelphia, Pennsylvania, United States
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- Avera Cancer Institute — Sioux Falls, South Dakota, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
- University of Texas Southwestern Medical Center — Dallas, Texas, United States
- Virginia Cancer Specialists, PC — Fairfax, Virginia, United States
- University of Wisconsin Clinical Science Center — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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