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)
NCT05375604 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2023-06-01
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).
Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Gastric Cancer Metastatic to Liver
- Colorectal Cancer Metastatic to Liver
Interventions
- DRUG
-
CDK-004
ASO-STAT6 exosome administered Intravenously
Sponsors & Collaborators
-
Codiak BioSciences
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-28
- Primary Completion
- 2023-05-25
- Completion
- 2023-05-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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