Phase
Condition
Neoplasms
Treatment
ABL503
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically and/or cytologically confirmed diagnosis of any progressive locallyadvanced (unresectable) or metastatic solid tumors that have relapsed or arerefractory following the last line of treatment, for which prior standard therapyhas been ineffective, standard therapy does not exist, or is not consideredappropriate.
With AE(s) excluding alopecia or Grade 2 toxicities that are deemed stable orirreversible (eg, peripheral neuropathy) from prior therapy that have improved toGrade 1 or the baseline grade more than 14 days prior to the first administration ofthe study drug
Adequate hematologic, hepatic, and renal functions confirmed based on the screeninglaboratory tests and reconfirmed with additional safety laboratory tests performedwithin 72 hours prior to the first administration of ABL503
Exclusion
Exclusion Criteria:
Prior anticancer monoclonal antibody treatment or investigational therapy within 28days prior to the first administration of study drug or has not recovered (ie, ≤Grade 1 or at baseline grade) from AEs due to previously administered agent morethan 14 days prior to ABL503 administration
Prior chemotherapy or radiation therapy within 2 weeks or targeted small moleculetherapy within 5 half-lives prior to the first administration of study drug or hasnot recovered (ie, ≤ Grade 1 or at baseline grade) from AEs due to previouslyadministered agent more than 14 days prior to ABL503 administration
Requiring or received systemic steroid therapy or any other immunosuppressivetherapy within 14 days prior to study drug administration.
Risk factors for bowel obstruction or bowel perforation (including but not limitedto a history of acute diverticulitis, intra-abdominal abscess, and abdominalcarcinomatosis.
Discontinued from prior immunomodulatory therapy due to any intolerableimmune-related adverse events (IrAEs) requiring systemic steroid treatment
History of drug-induced pneumonitis (interstitial lung disease) or currently haspneumonitis
Received prior treatment with an anti-4-1BB antibody
Study Design
Connect with a study center
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
Severance Hospital
Seoul, 03722
Korea, Republic ofActive - Recruiting
City of Hope
Duarte, California 91010
United StatesActive - Recruiting
USC
LA, California 90033
United StatesActive - Recruiting
USC
Los Angeles, California 90033
United StatesSite Not Available
UCLA
Santa Monica, California 90404
United StatesActive - Recruiting
Sarah Cannon Research Institute at HealthONE
Denver, Colorado 80218
United StatesActive - Recruiting
NEXT Oncology
San Antonio, Texas 78229
United StatesActive - Recruiting
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