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

Last updated: September 2, 2025
Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Neoplasms

Treatment

FF-10832

Pembrolizumab

Clinical Study ID

NCT05318573
FF10832-PEM-201/KEYNOTE-B57
MK-3475-B57
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent is provided by patient or legally acceptablerepresentative;

  2. Age ≥ 18 years;

  3. Patient populations:

  4. In the Safety Run-in, patients with histologically or cytologically confirmedadvanced or metastatic solid tumors who have disease progression aftertreatment with standard therapies for metastatic disease that are known toconfer clinical benefit, or are intolerant to treatment or refuse standardtreatment will be enrolled in therapy

  5. In Expansion Phase, patient must have urothelial or NSCLC, and have failedprior anti-PD-1 or anti-PD-L1

  6. Have measurable disease per RECIST 1.1 as assessed by the local siteinvestigator/radiology

  7. Eastern Cooperative Oncology Group performance status of 0 to 1

  8. Life expectancy of ≥ 3 months

Exclusion

Exclusion Criteria:

  1. Positive urine pregnancy test within 72 hours prior to treatment

  2. Has received prior systemic anti-cancer therapy including investigational agentswithin 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 orwith 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 aGrade 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:

  6. 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;

  7. Patients with mutations (e.g., EGFR mutations or ALK gene rearrangements) willbe excluded unless they have been previously treated with all specific targetedtherapies.

  8. Has received a live or live-attenuated vaccine within 30 days prior to the firstdose of study intervention.

  9. Has had an allogeneic tissue /solid organ transplant.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: FF-10832
Phase: 2
Study Start date:
June 01, 2022
Estimated Completion Date:
November 30, 2029

Study 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 combination therapy with pembrolizumab; FF 10832 will be dosed at 40 mg/m2 with a fixed dose of pembrolizumab (200 mg).

After confirmation of the appropriate FF-10832 dose for use with pembrolizumab, the trial will enroll up to an additional 100 patients in 2 cohorts (urothelial cancer [UC] and non-small cell lung cancer [NSCLC]) into 4 separate expansion treatment arms (approximately 25 patients in each treatment arm). The disease-defined cohorts will be patients who have progressed on PD-1/PD-L1 therapy who have UC or NSCLC.

The UC cohort will be randomized (1:1) to one of two treatment arms (monotherapy or combination therapy) and the NSCLC cohort will be randomized (1:1) to one of two treatment arms (monotherapy or combination therapy), to further establish safety and gain preliminary information on antitumor activity of FF-10832 as monotherapy or in combination with pembrolizumab.

Connect with a study center

  • Cancer and Blood Speciality Clinic

    Long Beach, California 90806
    United States

    Site Not Available

  • Sharp Memorial Hospital (Oncology Clinical Research)

    San Diego, California 92123
    United States

    Site Not Available

  • Cancer and Blood Speciality Clinic

    Long Beach 5367929, California 5332921 90806
    United States

    Site Not Available

  • Sharp Memorial Hospital (Oncology Clinical Research)

    San Diego 5391811, California 5332921 92123
    United States

    Site Not Available

  • Sibley Memorial Hospital

    Washington, District of Columbia 20016
    United States

    Site Not Available

  • Sibley Memorial Hospital

    Washington D.C. 4140963, District of Columbia 4138106 20016
    United States

    Site Not Available

  • University of Kansas Cancer Center - Westwood

    Westwood, Kansas 66205
    United States

    Site Not Available

  • University of Kansas Cancer Center - Westwood

    Westwood 4281639, Kansas 4273857 66205
    United States

    Site Not Available

  • University of Kentucky Medical Center

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • University of Louisville Brown Cancer Center

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • University of Kentucky Medical Center

    Lexington 4297983, Kentucky 6254925 40536
    United States

    Site Not Available

  • University of Louisville Brown Cancer Center

    Louisville 4299276, Kentucky 6254925 40202
    United States

    Site Not Available

  • Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

  • Washington University School of Medicine, Center for Adv Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine, Center for Adv Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Nebraska Cancer Specialists - Legacy

    Omaha, Nebraska 68130
    United States

    Site Not Available

  • Nebraska Cancer Specialists - Legacy

    Omaha 5074472, Nebraska 5073708 68130
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada - Southern Hills

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada - Southern Hills

    Las Vegas 5506956, Nevada 5509151 89148
    United States

    Site Not Available

  • Atlantic Health System / Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Atlantic Health System / Morristown Medical Center

    Morristown 5101427, New Jersey 5101760 07960
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • NYU Langone Health

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • TriHealth Cancer Institute; Good Samaritan Hospital

    Cincinnati, Ohio 45220
    United States

    Site Not Available

  • TriHealth Cancer Institute; Good Samaritan Hospital

    Cincinnati 4508722, Ohio 5165418 45220
    United States

    Site Not Available

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon 97213
    United States

    Site Not Available

  • Providence Cancer Institute Franz Clinic

    Portland 5746545, Oregon 5744337 97213
    United States

    Site Not Available

  • Hospital of the Univ of Pennsylvania Perlman Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Hospital of the Univ of Pennsylvania Perlman Center

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • UPMC Hillman Cancer Center

    Pittsburgh 5206379, Pennsylvania 6254927 15232
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Avera Cancer Institute

    Sioux Falls 5231851, South Dakota 5769223 57105
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75235
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75235
    United States

    Site Not Available

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Virginia Cancer Specialists, PC

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • University of Wisconsin Clinical Science Center

    Madison 5261457, Wisconsin 5279468 53792
    United States

    Site Not Available

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