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A First-in-Human Study of CDK-002 (exoSTING) in Subjects With Advanced/Metastatic, Recurrent, Injectable Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04592484
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : May 20, 2022
Information provided by (Responsible Party):
Codiak BioSciences

Brief 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. 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).

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Biological: CDK-002 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: CDK-002 Biological: CDK-002
CDK-002 administered intratumorally

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Criteria for Inclusion:

  1. Age ≥ 18 years at the time of signing the informed consent form.
  2. Histologically confirmed advanced, recurrent or metastatic injectable solid tumor and has received the following prior therapy:

    1. HNSCC: Subject must have been previously treated with a platinum-based chemotherapy regimen and/or a programmed cell death-protein 1 (PD-1) inhibitor.
    2. TNBC: Subject must have been treated with at least 1 chemotherapy regimen and/or PD-L1 or PD-1 inhibitor for metastatic disease.
    3. ATC: Subject must be considered inoperable and not considered to benefit from additional chemotherapy and/or radiation.
    4. cSCC: Subject must have previously been treated with radiation therapy and/or chemotherapy and/or PD-L1 or PD-1 inhibitor.
    5. 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.
  3. 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.
  4. 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.
  5. Understands and can comply with the study requirements and has signed the informed consent form.
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  7. Life expectancy of at least 3 months.
  8. Acceptable liver function.
  9. Acceptable renal function.
  10. Acceptable hematologic status.
  11. Negative serum pregnancy test (for women of child-bearing potential) within 72 hours before the first dose of CDK-002.

Exclusion Criteria:

Criteria for Exclusion:

  1. Prior treatment with a STING agonist.
  2. 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.
  3. Small-molecule kinase inhibitors or hormonal anticancer agents within 14 days prior to the first dose of CDK 002.
  4. Clinically significant ongoing AEs that have not returned to baseline or to Grade 1 NCI CTCAE v5.0.
  5. 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.
  6. 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.
  7. Clinically active central nervous system (CNS) metastases or carcinomatous meningitis. Subjects with stable brain metastasis may be enrolled with Sponsor approval.
  8. Metastatic liver involvement that exceeds one-third of total liver volume.
  9. 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.
  10. History of myocarditis.
  11. Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy. Prophylactic antibiotics are acceptable.
  12. Prior organ or stem cell transplant.
  13. Primary immune deficiency.
  14. Pregnant or nursing women.
  15. Active Hepatitis B or C infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04592484

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Contact: Katura Fetterson 617-949-4221

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United States, Arizona
Honor Health Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Shannon Pat    480-323-1796   
Principal Investigator: Frank Tsai, MD         
United States, New York
Columbia University/CUMC Recruiting
New York, New York, United States, 10032
Contact: Elizabeth Vann    212-305-5098   
Principal Investigator: Matthew Ingham, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jennifer Louie    215-220-9668   
Principal Investigator: Roger Cohen, MD         
United States, Texas
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Cynthia De Leon    210-580-9521   
Principal Investigator: Anthony Tolcher, MD         
United Kingdom
The Beatson West of Scotland Cancer Centre/ Gartnavel General Hospital Recruiting
Glasgow, United Kingdom, G12 0YN
Contact: Sophie Mason    +44 (0) 41 301 7215   
Sub-Investigator: Jeff Evans, MD         
Oxford University Hospitals NHS Trust Recruiting
Headington, United Kingdom, OX3 9DU
Contact: Richard Cousins    +44 (0) 865 572 048   
Principal Investigator: Eileen Parkes, MD         
The Royal Marsden Hospital Not yet recruiting
London, United Kingdom, SW3 6JJ
Contact: Abigail Crowhurst    +44 (0) 208 642 6011 ext 4020   
Principal Investigator: Kevin Harrington, MD         
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Sophie Walker    +44 (0) 161 918 7872   
Principal Investigator: Donna Graham, MD         
Sponsors and Collaborators
Codiak BioSciences
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Principal Investigator: Roger Cohen, MD University of Pennsylvania Hospital
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Responsible Party: Codiak BioSciences Identifier: NCT04592484    
Other Study ID Numbers: CDK-002-101
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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