Phase
Condition
Neoplasms
Treatment
FF-10832
Pembrolizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed consent is provided by patient or legally acceptablerepresentative;
Age ≥ 18 years;
Patient populations:
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
In Expansion Phase, patient must have urothelial or NSCLC, and have failedprior anti-PD-1 or anti-PD-L1
Have measurable disease per RECIST 1.1 as assessed by the local siteinvestigator/radiology
Eastern Cooperative Oncology Group performance status of 0 to 1
Life expectancy of ≥ 3 months
Exclusion
Exclusion Criteria:
Positive urine pregnancy test within 72 hours prior to treatment
Has received prior systemic anti-cancer therapy including investigational agentswithin 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 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;
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) willbe excluded unless they have been previously treated with all specific targetedtherapies.
Has received a live or live-attenuated vaccine within 30 days prior to the firstdose of study intervention.
Has had an allogeneic tissue /solid organ transplant.
Study Design
Study Description
Connect with a study center
Cancer and Blood Speciality Clinic
Long Beach, California 90806
United StatesActive - Recruiting
Sharp Memorial Hospital (Oncology Clinical Research)
San Diego, California 92123
United StatesActive - Recruiting
Sibley Memorial Hospital
Washington, District of Columbia 20016
United StatesActive - Recruiting
University of Kansas Cancer Center - Westwood
Westwood, Kansas 66205
United StatesActive - Recruiting
University of Kentucky Medical Center
Lexington, Kentucky 40536
United StatesActive - Recruiting
University of Louisville Brown Cancer Center
Louisville, Kentucky 40202
United StatesActive - Recruiting
Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)
Detroit, Michigan 48202
United StatesActive - Recruiting
Washington University School of Medicine, Center for Adv Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Nebraska Cancer Specialists - Legacy
Omaha, Nebraska 68130
United StatesActive - Recruiting
Comprehensive Cancer Centers of Nevada - Southern Hills
Las Vegas, Nevada 89148
United StatesActive - Recruiting
Atlantic Health System / Morristown Medical Center
Morristown, New Jersey 07960
United StatesCompleted
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
TriHealth Cancer Institute; Good Samaritan Hospital
Cincinnati, Ohio 45220
United StatesActive - Recruiting
Providence Cancer Institute Franz Clinic
Portland, Oregon 97213
United StatesActive - Recruiting
Hospital of the Univ of Pennsylvania Perlman Center
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesActive - Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United StatesActive - Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesCompleted
University of Texas Southwestern Medical Center
Dallas, Texas 75235
United StatesActive - Recruiting
Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
United StatesActive - Recruiting
University of Wisconsin Clinical Science Center
Madison, Wisconsin 53792
United StatesActive - Recruiting


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