Description:
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).
Title
- Brief Title: A First-in-Human Study of CDK-002 (exoSTING) in Subjects With Advanced/Metastatic, Recurrent, Injectable Solid Tumors
- 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
Clinical Trial IDs
- ORG STUDY ID:
CDK-002-101
- NCT ID:
NCT04592484
Conditions
Interventions
Drug | Synonyms | Arms |
---|
CDK-002 | | CDK-002 |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
CDK-002 | Experimental | | |
Eligibility Criteria
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | To determine the safety and tolerability of ascending doses of CDK-002 |
Time Frame: | up to 2 years |
Safety Issue: | |
Description: | Incidence of treatment-emergent adverse events as assessed by CTCAE |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Codiak BioSciences |
Last Updated
August 9, 2021