Phase
Condition
Neoplasms
Treatment
Pembrolizumab
ADU-1805
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female aged ≥18 years
Signed and dated informed consent form
Histologically and/or cytologically confirmed diagnosis of metastatic orunresectable solid tumors that are refractory to standard therapy or for which nostandard therapy exists
Measurable disease according to RECIST (Safety Expansion only)
ECOG Performance status of 0 or 1
Adequate organ and marrow function
Exclusion
Exclusion Criteria:
Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma andpancreatic ductal adenocarcinoma (PDAC)
Pregnancy or breast-feeding
Prior treatment with or receipt of:
biological agents, including monoclonal antibodies and immunotherapies, within 28 days prior to the first dose of ADU-1805
chemotherapy, targeted small molecule therapy, hormonal therapy or radiationtherapy within 21 days prior to the first dose of ADU-1805 and within 42 daysfor nitrosoureas and mitomycin C.
anti-SIRPα or anti-CD47-directed therapy
systemic chronic steroid therapy or immunosuppressive therapy within 14 daysprior to the first dose of ADU-1805
other investigational new drug or investigational device within 28 days priorto the first dose of ADU-1805
vaccine containing live virus within 28 prior to the first dose of ADU-1805
Active untreated brain metastases
Active infection requiring systemic therapy
Impaired cardiac function or clinically significant cardiac disease
Current Grade >2 toxicity related to prior anti-cancer therapy
History of drug-induced severe immune-related adverse reaction
Prior severe hypersensitivity to other monoclonal antibodies or ADU-1805 excipients
Major surgery within defined period
Diagnosis or positive test of HIV, hepatitis B, hepatitis C, or active tuberculosis
Allogenic tissue/solid organ transplant
Any intercurrent illness that is life-threatening or of such clinical significancethat it would interfere with the patient's safety or ability to participate in thestudy
Study Design
Study Description
Connect with a study center
Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame
Charleroi,
BelgiumActive - Recruiting
National Institute of Oncology
Chișinău,
Moldova, Republic ofActive - Recruiting
Hosp 12 de Octubre
Madrid,
SpainActive - Recruiting
Hospital General Universitario Gergorio Maranon
Madrid,
SpainActive - Recruiting
Henry Ford Cancer Institute
Detroit, Michigan 48202
United StatesActive - Recruiting
Washington University Medical Campus
St. Louis, Missouri 63110
United StatesActive - Recruiting
Carolina BioOncology Institute - Cancer Research Clinic
Huntersville, North Carolina 28078
United StatesActive - Recruiting
Gabrail Cancer & Research Center
Canton, Ohio 44718
United StatesActive - Recruiting
Virginia Cancer Specialists
FairFax, Virginia 22205
United StatesActive - Recruiting
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