Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate Safety, Efficacy of FF-10832 in Combo With Pembrolizumab in Urothelial & Non-small Cell Lung Cancer
Lead Sponsor:
Fujifilm Pharmaceuticals U.S.A., Inc.
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Advanced Urothelial Carcinoma
Advanced Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
This is a Phase 2a, open label clinical trial evaluating FF-10832 in combination with pembrolizumab and as monotherapy. The trial will begin with a safety run-in phase of 10 patients receiving combina...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05318573
Start Date
June 1 2022
End Date
November 1 2029
Last Update
September 4 2025
Active Locations (23)
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1
Cancer and Blood Speciality Clinic
Long Beach, California, United States, 90806
2
Sharp Memorial Hospital (Oncology Clinical Research)
San Diego, California, United States, 92123
3
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
4
University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States, 66205