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This is a first-in-human, Phase 1 open-label, multicenter, dose escalation, safety, pharmacodynamic, and PK study of exoASO-STAT6 (CDK-004) in patients with advanced Hepatocellular Carcinoma (HCC) and patients with liver metastases from either primary gastric cancer or colorectal cancer (CRC).
Full description
CDK-004 as an intravenous (IV) treatment for advanced hepatocellular carcinoma (HCC), and primary gastric cancer or CRC with secondary liver metastases.
CDK-004 is an investigational therapeutic candidate consisting of cell-derived exosomes loaded with a synthetic lipid-tagged oligonucleotide.
CDK-004 is designed to allow for specific delivery of the STAT6 anti-sense oligonucleotide (ASO) to the myloid to repolarize macrophage from immune suppressive M2 to proinflammatory M1 phenotype, with a potential for meaningful single agent antitumor activity which has not been observed with other pathway inhibitors to date.
CDK-004 will be administered as a single agent intravenously (IV) at various doses.
Dose limiting toxicities (DLTs) will be assessed during the study.
Enrollment
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Volunteers
Inclusion criteria
Must have one of the following cancer types:
Documented progression after at least 1 line of FDA approved systemic therapy for advanced HCC/gastric cancer/CRC or intolerable/refuse to chemotherapy.
≥ 18 years of age at screening.
Measurable disease by RECIST v1.1.
Able to provide archival tumor tissue/fresh biopsy prior to study treatment and on-treatment tumor biopsies if considered safe and medically feasible by the Investigator.
ECOG performance status of 0-2.
Acceptable liver function
Acceptable renal function
Acceptable hematologic status
Cirrhosis classified as Child-Pugh Class A (applicable only to patients diagnosed with cirrhosis)..
Women of child-bearing potential agree to use highly effective contraceptive methods and avoid egg donation and preservation during the study treatment and for 6 months after the last dose of study drug.
Men of child-producing potential agree to use highly effective contraceptive methods and avoid sperm donation and preservation during the study treatment and for 6 months after the last dose of study drug.
Exclusion criteria
Primary purpose
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9 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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