Trials / Terminated
TerminatedNCT05375604
A 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)
Phase 1 Study of Macrophage Reprogramming Agent, 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)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Codiak BioSciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed 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.
Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Gastric Cancer Metastatic to Liver
- Colorectal Cancer Metastatic to Liver
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CDK-004 | ASO-STAT6 exosome administered Intravenously |
Timeline
- Start date
- 2022-06-28
- Primary completion
- 2023-05-25
- Completion
- 2023-05-30
- First posted
- 2022-05-16
- Last updated
- 2023-06-01
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05375604. Inclusion in this directory is not an endorsement.