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About
This is Phase 1, Multicenter, Open-Label, Dose-Escalation and Dose-Exploration Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of AK119 (Anti-CD73) in Subjects with Advanced or Metastatic Solid Tumors.
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
Prior malignancy active within the previous 3 years except for the tumor for which a subject is enrolled in the study, and locally curable cancers that have been apparently cured.
Receipt of the following treatments or procedures:
Subjects with history of brain metastases that have been treated may participate provided they show evidence of stable supra-tentorial lesions at Screening;
Brain stem metastasis, meningeal metastasis, spinal cord metasasis or compression;
Uncontrolled massive ascites, pleural effusion or pericardial effusion, as determined by the Investigator;
Known history of human immunodeficiency virus (HIV) infection;
Known active hepatitis B or C infections (Active hepatitis B is defined as a known positive Hepatitis B surface antigen [HBsAg] result. Active hepatitis C is defined by a known positive Hepatitis C virus [HCV] antibody with detectable HCV ribonucleic acid [RNA] results);
Active autoimmune diseases or history of autoimmune diseases that may relapse;
History of interstitial lung disease, noninfectious pneumonitis except for those induced by radiation therapies;
Patients with clinically significant cardio-cerebrovascular or venous thromboembolic disease;
Toxicities of prior anticancer therapy have not resolved to NCI-CTCAE version 5.0 Grade ≤1, or to levels dictated in the inclusion/exclusion criteria, except toxicities not considered a safety risk (e.g., alopecia, neuropathy, or asymptomatic laboratory abnormalities);
History of severe hypersensitivity reactions to other mAbs;
Prior organ transplantation;
Any condition that required systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of investigational product;
Receipt of live attenuated vaccines within 4 weeks prior to the first dose of investigational product; Note: seasonal vaccine for influenza which is generally inactivated is allowed;
Any other conditions that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
Primary purpose
Allocation
Interventional model
Masking
16 participants in 1 patient group
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Central trial contact
Ting Liu, MD
Data sourced from clinicaltrials.gov
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