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 StatesSite Not Available
Sharp Memorial Hospital (Oncology Clinical Research)
San Diego, California 92123
United StatesSite Not Available
Cancer and Blood Speciality Clinic
Long Beach 5367929, California 5332921 90806
United StatesSite Not Available
Sharp Memorial Hospital (Oncology Clinical Research)
San Diego 5391811, California 5332921 92123
United StatesSite Not Available
Sibley Memorial Hospital
Washington, District of Columbia 20016
United StatesSite Not Available
Sibley Memorial Hospital
Washington D.C. 4140963, District of Columbia 4138106 20016
United StatesSite Not Available
University of Kansas Cancer Center - Westwood
Westwood, Kansas 66205
United StatesSite Not Available
University of Kansas Cancer Center - Westwood
Westwood 4281639, Kansas 4273857 66205
United StatesSite Not Available
University of Kentucky Medical Center
Lexington, Kentucky 40536
United StatesSite Not Available
University of Louisville Brown Cancer Center
Louisville, Kentucky 40202
United StatesSite Not Available
University of Kentucky Medical Center
Lexington 4297983, Kentucky 6254925 40536
United StatesSite Not Available
University of Louisville Brown Cancer Center
Louisville 4299276, Kentucky 6254925 40202
United StatesSite Not Available
Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)
Detroit, Michigan 48202
United StatesSite Not Available
Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)
Detroit 4990729, Michigan 5001836 48202
United StatesSite Not Available
Washington University School of Medicine, Center for Adv Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine, Center for Adv Medicine
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
Nebraska Cancer Specialists - Legacy
Omaha, Nebraska 68130
United StatesSite Not Available
Nebraska Cancer Specialists - Legacy
Omaha 5074472, Nebraska 5073708 68130
United StatesSite Not Available
Comprehensive Cancer Centers of Nevada - Southern Hills
Las Vegas, Nevada 89148
United StatesSite Not Available
Comprehensive Cancer Centers of Nevada - Southern Hills
Las Vegas 5506956, Nevada 5509151 89148
United StatesSite Not Available
Atlantic Health System / Morristown Medical Center
Morristown, New Jersey 07960
United StatesSite Not Available
Atlantic Health System / Morristown Medical Center
Morristown 5101427, New Jersey 5101760 07960
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
NYU Langone Health
New York, New York 10016
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
United StatesSite Not Available
NYU Langone Health
New York 5128581, New York 5128638 10016
United StatesSite Not Available
TriHealth Cancer Institute; Good Samaritan Hospital
Cincinnati, Ohio 45220
United StatesSite Not Available
TriHealth Cancer Institute; Good Samaritan Hospital
Cincinnati 4508722, Ohio 5165418 45220
United StatesSite Not Available
Providence Cancer Institute Franz Clinic
Portland, Oregon 97213
United StatesSite Not Available
Providence Cancer Institute Franz Clinic
Portland 5746545, Oregon 5744337 97213
United StatesSite Not Available
Hospital of the Univ of Pennsylvania Perlman Center
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
Hospital of the Univ of Pennsylvania Perlman Center
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
UPMC Hillman Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927 15232
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United StatesSite Not Available
Avera Cancer Institute
Sioux Falls 5231851, South Dakota 5769223 57105
United StatesSite Not Available
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesSite Not Available
Sarah Cannon Research Institute
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
University of Texas Southwestern Medical Center
Dallas, Texas 75235
United StatesSite Not Available
University of Texas Southwestern Medical Center
Dallas 4684888, Texas 4736286 75235
United StatesSite Not Available
Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
United StatesSite Not Available
Virginia Cancer Specialists, PC
Fairfax 4758023, Virginia 6254928 22031
United StatesSite Not Available
University of Wisconsin Clinical Science Center
Madison, Wisconsin 53792
United StatesSite Not Available
University of Wisconsin Clinical Science Center
Madison 5261457, Wisconsin 5279468 53792
United StatesSite Not Available

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