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)

May 30, 2023 updated by: Codiak BioSciences

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)

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Must have one of the following cancer types:

    1. Advanced HCC defined as Barcelona Clinic Liver Cancer (BCLC) Stage B/C not amenable to resection or locoregional therapy;
    2. Histologic or radiologic proof of liver metastasis from primary CRC which is unresectable with no evidence of extrahepatic metastasis;
    3. Histologic or radiologic proof of liver metastasis from primary gastric cancer which is unresectable with no evidence of extrahepatic metastasis.
  2. Documented progression after at least 1 line of FDA approved systemic therapy for advanced HCC/gastric cancer/CRC or intolerable/refuse to chemotherapy.
  3. ≥ 18 years of age at screening.
  4. Measurable disease by RECIST v1.1.
  5. 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.
  6. ECOG performance status of 0-2.
  7. Acceptable liver function
  8. Acceptable renal function
  9. Acceptable hematologic status
  10. Cirrhosis classified as Child-Pugh Class A (applicable only to patients diagnosed with cirrhosis)..
  11. 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.
  12. 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:

  1. Treatment with any systemic or liver-directed anticancer therapy within 3 weeks of the first dose of study drug.
  2. Uncontrolled partial or complete biliary obstruction.
  3. Left ventricular ejection fraction (LVEF) < 50% at Screening.
  4. 12-lead ECG demonstrating QT interval corrected by Fridericia's formula (QTcF) > 480 ms or history of long QTc syndrome.
  5. Ongoing, clinically significant AEs due to prior anticancer therapies.
  6. Patients with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present or in the opinion of the Investigator will not affect patient outcome.
  7. Known clinically active brain metastases or known carcinomatous meningitis/leptomeningeal disease.
  8. Known clinically significant infection.
  9. Known clinically significant cardiac disease, including unstable angina or has had a procedure to address the underlying cause and has experienced angina within 4 weeks prior to Cycle 1 Day 1, acute myocardial infarction within 6 months from Day 1 of study drug administration, or New York Heart Association Class III or IV congestive heart failure.
  10. Known history of human immunodeficiency virus (HIV).
  11. If history of concurrent Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection, meets the following criteria: patients with detectable hepatitis B surface antigen (HbsAg) or detectable HBV DNA should be managed per local treatment guidelines. Controlled (treated) hepatitis B patients will be allowed if they started treatment at the time of consent and treatment is continued during study participation; patients with hepatitis C and detectable RNA are eligible if antiviral therapy has been completed prior to first administration of study drug. Testing does not need to be conducted at Screening if results from testing within the past 12 months are available.
  12. History of liver transplant.
  13. History of immunodeficiency or is receiving chronic systemic steroid therapy
  14. Poorly controlled diabetes mellitus.
  15. Active or previously documented autoimmune or inflammatory diseases
  16. Is currently participating in a study of an investigational therapy or device or has participated and received an investigation therapy or device within 3 weeks of administration of CDK-004.
  17. Has another physical or mental health disorder that might cause difficulty in obtaining informed consent and/or participation in the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental CDK-004
CDK-004 administered as a single agent intravenously (IV) on Days 1 and 15 of Cycles 1 and 2, on Day 1 of every Cycle.
Drug: CDK-004
ASO-STAT6 exosome administered Intravenously
Other Names:
  • exoASO-STAT6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To characterize the safety and tolerability of CDK-004.
Time Frame: Up to 2 years
Incidence of treatment-emergent adverse events as assessed by CTCAE 5.0.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Codiak BioSciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2022

Primary Completion (Actual)

May 25, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

May 11, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (Actual)

May 16, 2022

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDK-004-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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