ACTIVE_NOT_RECRUITING

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

Conditions

Advanced Urothelial Carcinoma Advanced Non Small Cell Lung Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-06-01

Study Completion:2029-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05318573

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Locations (Sites)

Cancer and Blood Speciality Clinic

Long Beach, California, 90806

United States

Sharp Memorial Hospital (Oncology Clinical Research)

San Diego, California, 92123

United States

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016

United States

University of Kansas Cancer Center - Westwood

Westwood, Kansas, 66205

United States

University of Kentucky Medical Center

Lexington, Kentucky, 40536

United States

University of Louisville Brown Cancer Center

Louisville, Kentucky, 40202

United States

Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)

Detroit, Michigan, 48202

United States

Washington University School of Medicine, Center for Adv Medicine

St Louis, Missouri, 63110

United States

Nebraska Cancer Specialists - Legacy

Omaha, Nebraska, 68130

United States

Comprehensive Cancer Centers of Nevada - Southern Hills

Las Vegas, Nevada, 89148

United States

Atlantic Health System / Morristown Medical Center

Morristown, New Jersey, 07960

United States

NYU Langone Health

New York, New York, 10016

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

TriHealth Cancer Institute; Good Samaritan Hospital

Cincinnati, Ohio, 45220

United States

Providence Cancer Institute Franz Clinic

Portland, Oregon, 97213

United States

Hospital of the Univ of Pennsylvania Perlman Center

Philadelphia, Pennsylvania, 19104

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Avera Cancer Institute

Sioux Falls, South Dakota, 57105

United States

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75235

United States

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031

United States

University of Wisconsin Clinical Science Center

Madison, Wisconsin, 53792

United States

Collaborators and Investigators

Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-01

Study Completion Date2029-11

Study Record Updates

Study Start Date2022-06-01

Study Completion Date2029-11

Terms related to this study

Additional Relevant MeSH Terms

Advanced Urothelial Carcinoma
Advanced Non Small Cell Lung Cancer