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Anti-metabolites

FF-10832 + Pembrolizumab for Cancer

Phase 2
Recruiting
Research Sponsored by Fujifilm Pharmaceuticals U.S.A., Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient populations in the Expansion Phase: patient must have urothelial or NSCLC, and have failed prior anti-PD-1 or anti-PD-L1
Patient must have Eastern Cooperative Oncology Group performance status of 0 to 1
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

This trial is testing a new cancer drug, given in combination with another drug that is already used to treat cancer.

Who is the study for?
Adults (18+) with advanced solid tumors that have worsened after standard treatments, or those who cannot tolerate or refuse such treatments. They must be able to consent, have a life expectancy of at least 3 months, and an ECOG performance status of 0-1. Pregnant individuals, recent recipients of certain cancer therapies or vaccines, and patients with specific genetic mutations not previously treated are excluded.
What is being tested?
The trial is testing the combination of FF-10832 (a liposome injection) and Pembrolizumab in adults with advanced solid tumors. FF-10832 is given intravenously on Day 1 every three weeks alongside Pembrolizumab to determine the safety and effective dose for Phase 2 trials.
What are the potential side effects?
Possible side effects include reactions related to immune system activation which may affect organs, infusion-related reactions from the IV treatment process, fatigue due to treatment burden on the body's resources, as well as potential impacts on blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have urothelial or NSCLC cancer and previous treatments targeting PD-1 or PD-L1 didn't work for me.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a live vaccine in the last 30 days.
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I have received an organ or tissue transplant from another person.
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I haven't had cancer treatment or experimental drugs in the last 4 weeks.
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I stopped a cancer immunotherapy due to severe side effects.
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I haven't had lung radiation over 30 Gy in the last 6 months and have tried all treatments for my lung cancer mutations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine the incidence of Treament Emergent Adverse Events (TEAE)
Duration of Stable Disease in Combination Therapy
Duration of Stable Disease in Monotherapy
Secondary study objectives
Determine Safety Profile of Combination Therapy
Determine Safety Profile of Monotherapy
Duration of Response (DOR)
+3 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: Urothelial Monotherapy - FF-10832 Expansion PhaseExperimental Treatment1 Intervention
FF-10832 will be dosed at 40 mg/m2
Group II: Urothelial Combination - FF-10832 + pembrolizumab Expansion PhaseExperimental Treatment2 Interventions
FF-10832 in combination therapy with pembrolizumab; FF-10832 will be dosed at 40 mg/m2 with a fixed dose of pembrolizumab (200 mg)
Group III: Safety Run-in PhaseExperimental Treatment2 Interventions
FF-10832 in combination therapy with pembrolizumab; FF-10832 will be dosed at 40 mg/m2 with a fixed dose of pembrolizumab (200 mg)
Group IV: NSCLC Monotherapy - FF-10832 Expansion PhaseExperimental Treatment1 Intervention
FF-10832 will be dosed at 40 mg/m2
Group V: NSCLC Combination - FF-10832 + pembrolizumab Expansion PhaseExperimental Treatment2 Interventions
FF-10832 in combination therapy with pembrolizumab; FF-10832 will be dosed at 40 mg/m2 with a fixed dose of pembrolizumab (200 mg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
4,005 Previous Clinical Trials
5,185,301 Total Patients Enrolled
Fujifilm Pharmaceuticals U.S.A., Inc.Lead Sponsor
8 Previous Clinical Trials
546 Total Patients Enrolled

Media Library

FF-10832 (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05318573 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Safety Run-in Phase, Urothelial Combination - FF-10832 + pembrolizumab Expansion Phase, Urothelial Monotherapy - FF-10832 Expansion Phase, NSCLC Combination - FF-10832 + pembrolizumab Expansion Phase, NSCLC Monotherapy - FF-10832 Expansion Phase
Non-Small Cell Lung Cancer Clinical Trial 2023: FF-10832 Highlights & Side Effects. Trial Name: NCT05318573 — Phase 2
FF-10832 (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05318573 — Phase 2
~77 spots leftby May 2029
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