Advanced Solid TumorPhase 1/2NCT04592484
A First-in-Human Study of CDK-002 (exoSTING) in Subjects With Advanced/Metastatic, Recurrent, Injectable Solid Tumors
A Phase 1/2 study testing CDK-002 in people with Advanced Solid Tumor, run by Codiak BioSciences at 8 sites in 2 countries.
Trial summary
This is a first-in-human, Phase 1/2 open-label, multicenter, dose escalation, safety, pharmacodynamic, and PK study of CDK-002 in subjects with advanced/metastatic, recurrent, injectable solid tumors, whose disease has progressed despite receiving standard of care treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- CDK-002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 15 Sep 2020to 23 Dec 2022
- Phase
- Phase 1/2
- 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
- Criteria for Inclusion:
- Age ≥ 18 years at the time of signing the informed consent form.
- Histologically confirmed advanced, recurrent or metastatic injectable solid tumor and has received the following prior therapy:
- HNSCC: Subject must have been previously treated with a platinum-based chemotherapy regimen and/or a programmed cell death-protein 1 (PD-1) inhibitor.
- TNBC: Subject must have been treated with at least 1 chemotherapy regimen and/or PD-L1 or PD-1 inhibitor for metastatic disease.
- ATC: Subject must be considered inoperable and not considered to benefit from additional chemotherapy and/or radiation.
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- cSCC: Subject must have previously been treated with radiation therapy and/or chemotherapy and/or PD-L1 or PD-1 inhibitor.
- Subjects with other advanced solid tumors that have progressed following standard therapy or for which there is no standard of care therapy with an overall survival (OS) benefit.
- Measurable disease per RECIST v1.1 and ≥1 lesion that is measurable (ie, ≥1.0 cm by CT, MRI, or ruler or caliper measurements for cutaneous lesions or other superficial lesions in longest diameter [non-lymph nodes] or ≥1.5 cm in shortest diameter for lymph nodes) and amenable to tumoral injection and biopsy per Investigator assessment.
- Agrees to have a pre-treatment tumor biopsy within 7 days prior to the first dose of CDK-002, and 2 on-treatment tumor biopsies of the same lesion. Biopsies may be core needle, incisional, or excisional biopsies. For cutaneous lesions, a punch biopsy may be acceptable. Fine needle aspiration (FNA) is not acceptable.
- Understands and can comply with the study requirements and has signed the informed consent form.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Life expectancy of at least 3 months.
- Acceptable liver function.
- Acceptable renal function.
- Acceptable hematologic status.
- Negative serum pregnancy test (for women of child-bearing potential) within 72 hours before the first dose of CDK-002.
Who cannot join
- Criteria for Exclusion:
- Prior treatment with a STING agonist.
- Cytotoxic chemotherapy, biologic agents, investigational agents, or radiation therapy within 4 weeks prior to the first dose of CDK 002 (6 weeks for nitrosoureas or mitomycin C). The interval can be reduced to 2 weeks for bone-only radiation therapy.
- Small-molecule kinase inhibitors or hormonal anticancer agents within 14 days prior to the first dose of CDK 002.
- Clinically significant ongoing AEs that have not returned to baseline or to Grade 1 NCI CTCAE v5.0.
- Immunosuppressive agents including corticosteroids within 14 days of first dose of CDK 002. Topical, intranasal or inhaled corticosteroids, physiologic doses of systemic steroids or limited treatment with systemic steroids (ie, for IV contrast prophylaxis) may be administered with Sponsor approval.
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- Major surgery within 6 weeks or minor surgery (excluding tumor biopsies) within 14 days prior to the first dose of CDK 002 or if subject has not clinically recovered.
- Clinically active central nervous system (CNS) metastases or carcinomatous meningitis. Subjects with stable brain metastasis may be enrolled with Sponsor approval.
- Metastatic liver involvement that exceeds one-third of total liver volume.
- Clinically significant cardiovascular disease including but not limited to New York Heart Association Class III or IV heart failure, myocardial infarction or stroke within the past 6 months prior to the first dose of CDK 002, uncontrolled arrhythmia, or severe aortic stenosis. Sponsor approval of subjects with an arrhythmia is required.
- History of myocarditis.
- Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy. Prophylactic antibiotics are acceptable.
- Prior organ or stem cell transplant.
- Primary immune deficiency.
- Pregnant or nursing women.
- Active Hepatitis B or C infection.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States4 sites
Columbia University/CUMC
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
NEXT Oncology
San Antonio, Texas, 78229
Honor Health
Scottsdale, Arizona, 85258
United Kingdom4 sites
The Beatson West of Scotland Cancer Centre/ Gartnavel General Hospital
Glasgow, G12 0YN
Oxford University Hospitals NHS Trust
Headington, OX3 9DU
The Royal Marsden Hospital
London, SW3 6JJ
The Christie NHS Foundation Trust
Manchester, M20 4BX
About this study
Official title: A First-in-Human Study of CDK-002 (exoSTING) in Subjects With Advanced/Metastatic, Recurrent, Injectable Solid Tumors, With Emphasis on Squamous Cell Carcinoma of the Head and Neck, Triple Negative Breast Cancer, Anaplastic Thyroid Carcinoma, and Cutaneous Squamous Cell Carcinoma
This is a first-in-human, Phase 1/2 open-label, multicenter, dose escalation, safety, pharmacodynamic, and PK study of CDK-002 in subjects with advanced/metastatic, recurrent, injectable solid tumors, whose disease has progressed despite receiving standard of care treatment. CDK 002 will be administered intratumorally (IT).
Part A will enroll subjects with advanced/metastatic, recurrent, injectable solid tumors with emphasis on head and neck squamous cell cancer (HNSCC), triple negative breast cancer (TNBC), anaplastic thyroid carcinoma (ATC) and cutaneous squamous cell carcinoma (cSCC).
- Conditions
- Advanced Solid Tumor
- Being tested
- CDK-002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDK-002Biological
CDK-002 administered intratumorally
| Study group | Role | What they receive |
|---|---|---|
| CDK-002 | Experimental | Not described Receives: Biological: CDK-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of ascending doses of CDK-002
Incidence of treatment-emergent adverse events as assessed by CTCAE
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 posted19 Oct 2020
- Study start15 Sep 2020
- Primary completion3 Aug 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Codiak BioSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Cohen, MD, Principal investigator, University of Pennsylvania Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592484
- Sponsor's protocol ID
- CDK-002-101
- Status last verified
- Feb 2023
- First submitted
- 18 Aug 2020
- Last updated
- 8 Feb 2023
- Results posted
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study of CDK-002 (exoSTING) in Subjects With Advanced/Metastatic, Recurrent, Injectable Solid Tumors, With Emphasis on Squamous Cell Carcinoma of the Head and Neck, Triple Negative Breast Cancer, Anaplastic Thyroid Carcinoma, and Cutaneous Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04592484
- Acronym / sponsor ID
- CDK-002-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Codiak BioSciencesIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 19 Oct 2020 (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 1/2 open-label, multicenter, dose escalation, safety, pharmacodynamic, and PK study of CDK-002 in subjects with advanced/metastatic, recurrent, injectable solid tumors, whose disease has progressed despite receiving standard of care treatment. CDK 002 will be administered intratumorally (IT).
Part A will enroll subjects with advanced/metastatic, recurrent, injectable solid tumors with emphasis on head and neck squamous cell cancer (HNSCC), triple negative breast cancer (TNBC), anaplastic thyroid carcinoma (ATC) and cutaneous squamous cell carcinoma (cSCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDK-002 | Experimental | Biological: CDK-002 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥ 18 years at the time of signing the informed consent form.
- Histologically confirmed advanced, recurrent or metastatic injectable solid tumor and has received the following prior therapy:
- Measurable disease per RECIST v1.1 and ≥1 lesion that is measurable (ie, ≥1.0 cm by CT, MRI, or ruler or caliper measurements for cutaneous lesions or other superficial lesions in longest diameter [non-lymph nodes] or ≥1.5 cm in shortest diameter for lymph nodes) and amenable to tumoral injection and biopsy per Investigator assessment.
- Agrees to have a pre-treatment tumor biopsy within 7 days prior to the first dose of CDK-002, and 2 on-treatment tumor biopsies of the same lesion. Biopsies may be core needle, incisional, or excisional biopsies. For cutaneous lesions, a punch biopsy may be acceptable. Fine needle aspiration (FNA) is not acceptable.
- Understands and can comply with the study requirements and has signed the informed consent form.
Key exclusion criteria (16 listed)
- Prior treatment with a STING agonist.
- Cytotoxic chemotherapy, biologic agents, investigational agents, or radiation therapy within 4 weeks prior to the first dose of CDK 002 (6 weeks for nitrosoureas or mitomycin C). The interval can be reduced to 2 weeks for bone-only radiation therapy.
- Small-molecule kinase inhibitors or hormonal anticancer agents within 14 days prior to the first dose of CDK 002.
- Clinically significant ongoing AEs that have not returned to baseline or to Grade 1 NCI CTCAE v5.0.
- Immunosuppressive agents including corticosteroids within 14 days of first dose of CDK 002. Topical, intranasal or inhaled corticosteroids, physiologic doses of systemic steroids or limited treatment with systemic steroids (ie, for IV contrast prophylaxis) may be administered with Sponsor approval.
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-002CDK-002 administered intratumorally | Biological | CDK-002 |
Primary outcome
To determine the safety and tolerability of ascending doses of CDK-002
Time frame: up to 2 years
Incidence of treatment-emergent adverse events as assessed by CTCAE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 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.
Roger Cohen, MD principal investigator
University of Pennsylvania Hospital
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CDK-002 in people with Advanced Solid Tumor, run by Codiak BioSciences at 8 sites in 2 countries.
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 17 inclusion and 16 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: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, United Kingdom. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 determine the safety and tolerability of ascending doses of CDK-002 (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 8 Feb 2023.