Advanced Hepatocellular Carcinoma (HCC)Phase 1NCT05375604
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)
A Phase 1 study testing CDK-004 in people with Advanced Hepatocellular Carcinoma (HCC) and Gastric Cancer Metastatic to Liver, run by Codiak BioSciences at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Hepatocellular Carcinoma (HCC), Gastric Cancer Metastatic to Liver, Colorectal Cancer Metastatic to Liver
- What is being tested?
- CDK-004
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Jun 2022to 30 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have one of the following cancer types:
- Advanced HCC defined as Barcelona Clinic Liver Cancer (BCLC) Stage B/C not amenable to resection or locoregional therapy;
- Histologic or radiologic proof of liver metastasis from primary CRC which is unresectable with no evidence of extrahepatic metastasis;
- Histologic or radiologic proof of liver metastasis from primary gastric cancer which is unresectable with no evidence of extrahepatic metastasis.
- 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.
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- 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.
Who cannot join
- Treatment with any systemic or liver-directed anticancer therapy within 3 weeks of the first dose of study drug.
- Uncontrolled partial or complete biliary obstruction.
- Left ventricular ejection fraction (LVEF) < 50% at Screening.
- 12-lead ECG demonstrating QT interval corrected by Fridericia's formula (QTcF) > 480 ms or history of long QTc syndrome.
- Ongoing, clinically significant AEs due to prior anticancer therapies.
- 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.
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- Known clinically active brain metastases or known carcinomatous meningitis/leptomeningeal disease.
- Known clinically significant infection.
- 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.
- Known history of human immunodeficiency virus (HIV).
- 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.
- History of liver transplant.
- History of immunodeficiency or is receiving chronic systemic steroid therapy
- Poorly controlled diabetes mellitus.
- Active or previously documented autoimmune or inflammatory diseases
- 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.
- Has another physical or mental health disorder that might cause difficulty in obtaining informed consent and/or participation in the trial
Trial locations and contacts
3 sites in 1 country.
United States3 sites
City of Hope National Medical Center
Duarte, California, 91010
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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).
Read the 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
- Being tested
- CDK-004
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDK-004Drug
Also called exoASO-STAT6
ASO-STAT6 exosome administered Intravenously
| Study group | Role | What they receive |
|---|---|---|
| Experimental CDK-004 | Experimental | 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. Receives: Drug: CDK-004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the safety and tolerability of CDK-004.
Incidence of treatment-emergent adverse events as assessed by CTCAE 5.0.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start28 Jun 2022
- Primary completion25 May 2023
- Study completion30 May 2023
Why it stopped: Company Bankruptcy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Codiak BioSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375604
- Sponsor's protocol ID
- CDK-004-101
- Status last verified
- May 2023
- First submitted
- 11 May 2022
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05375604
- Acronym / sponsor ID
- CDK-004-101
- Conditions
- Advanced Hepatocellular Carcinoma (HCC), Gastric Cancer Metastatic to Liver, Colorectal Cancer Metastatic to Liver
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company Bankruptcy
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Codiak BioSciencesIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental CDK-004 | Experimental | Drug: CDK-004CDK-004 administered as a single agent intravenously (IV) on Days 1 and 15 of Cycles 1 and 2, on Day 1 of every Cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (17 listed)
- Treatment with any systemic or liver-directed anticancer therapy within 3 weeks of the first dose of study drug.
- Uncontrolled partial or complete biliary obstruction.
- Left ventricular ejection fraction (LVEF) < 50% at Screening.
- 12-lead ECG demonstrating QT interval corrected by Fridericia's formula (QTcF) > 480 ms or history of long QTc syndrome.
- Ongoing, clinically significant AEs due to prior anticancer therapies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDK-004Also: exoASO-STAT6ASO-STAT6 exosome administered Intravenously | Drug | Experimental CDK-004 |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Company Bankruptcy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CDK-004 in people with Advanced Hepatocellular Carcinoma (HCC) and Gastric Cancer Metastatic to Liver, run by Codiak BioSciences at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Company Bankruptcy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize the safety and tolerability of CDK-004. (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.