A First-in-Human Study of CDK-002 (exoSTING) in Subjects With Advanced/Metastatic, Recurrent, Inj… (NCT04592484) | Clinical Trial Compass
CompletedPhase 1/2
A First-in-Human Study of CDK-002 (exoSTING) in Subjects With Advanced/Metastatic, Recurrent, Injectable Solid Tumors
United States, United Kingdom27 participantsStarted 2020-09-15
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. cSCC: Subject must have previously been treated with radiation therapy and/or chemotherapy and/or PD-L1 or PD-1 inhibitor.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the safety and tolerability of ascending doses of CDK-002
. 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.
Exclusion criteria
. 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.
. 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.