Pilot Study of CBX-12 Pharmacodynamics in Patients With Advanced Solid Tumors
National Cancer Institute (NCI)
Summary
This phase I trial studies how well CBX-12 works in treating patients with solid tumors that have spread from where they first started (primary site) to started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or other places in the body (metastatic). CBX-12 works by binding to a protein called TOP1 that is present inside the cells. This allows CBX-12 to kill the cancer cells by damaging their DNA, resulting in cancer cell death. This trial is being done to find out if this approach is better or worse than the usual approach for advanced cancers.
Description
PRIMARY OBJECTIVE: I. Assess the effects of CBX-12 on biomarkers of DDR in biopsy specimens from patients with advanced solid tumors at baseline and 24-30 hours post-first dose to establish the degree and duration of CBX-12 target engagement. SECONDARY OBJECTIVES: I. Assess the effects of CBX-12 on tumor TOP1 molecular response at baseline and 24-30 hours post-first dose. II. Determine any association between tumor TOP1 and DDR modulation and plasma exatecan concentrations. III. Evaluate the effects of CBX-12 on CD8 T cell infiltration and activation in tumor. IV. Determine the objective…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have histologically confirmed solid tumors with metastatic disease that have progressed after \>= 1 line of prior therapy * Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, with at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 20 mm (\>= 2 cm) by chest x-ray or as \>= 10 mm (\>= 1 cm) with CT scan, MRI, or calipers by clinical exam) * Patients must have a tumor s…
Interventions
- ProcedureBiopsy Procedure
Undergo tumor biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT scan
- DrugpH Low Insertion Peptide-exatecan Conjugate CBX-12
Given IV
Location
- National Cancer Institute Developmental Therapeutics ClinicBethesda, Maryland