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Evaluating FF-10832 with Pembrolizumab for Advanced Urothelial and Lung Cancer

A Phase 2a Study With Safety Run-in to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FF-10832 Monotherapy or in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

Phase 2 Interventional Fujifilm Pharmaceuticals U.S.A., Inc. · NCT05318573

This study is testing if a new treatment combining FF-10832 with pembrolizumab can help people with advanced bladder or lung cancer who haven't responded to previous therapies.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment120 (estimated)
Ages18 Years and up
SexAll
SponsorFujifilm Pharmaceuticals U.S.A., Inc. Industry-sponsored
Drugs / interventionsradiation, pembrolizumab
Locations23 sites (Long Beach, California and 22 other locations)
Trial IDNCT05318573 on ClinicalTrials.gov

What this trial studies

This Phase 2a clinical trial aims to assess the safety and efficacy of FF-10832, a Gemcitabine Liposome Injection, in combination with pembrolizumab for patients with advanced urothelial carcinoma and non-small cell lung cancer. The study will begin with a safety run-in phase involving 10 patients, followed by an expansion phase enrolling up to 100 additional patients. Participants will be randomized into treatment arms to evaluate the effectiveness of the combination therapy versus monotherapy. The trial specifically targets patients who have progressed after prior PD-1/PD-L1 therapy.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced urothelial carcinoma or non-small cell lung cancer who have failed prior anti-PD-1 or anti-PD-L1 therapies.

Not a fit: Patients who have not received prior anti-PD-1 or anti-PD-L1 therapies or those with other types of cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced urothelial and non-small cell lung cancer who have limited treatment alternatives.

How similar studies have performed: Other studies have shown promising results with similar combination therapies, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Long Beach, California and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Urothelial CarcinomaAdvanced Non Small Cell Lung Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.