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

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.
• ✓. 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.