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Recruiting Phase 1 NCT05691517

Testing How the Body Responds to the Drug CBX-12 in Patients With Advanced Solid Cancers

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Trial Parameters

Condition Advanced Malignant Solid Neoplasm
Sponsor National Cancer Institute (NCI)
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 35
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-06-12
Completion 2026-10-15
Interventions
Biopsy ProcedureBiospecimen CollectionComputed Tomography

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Brief 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.

Eligibility Criteria

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 site amenable to biopsy * Age \>= 18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Absolute neutrophil count \>= 1,500/mcL * Hemoglobin \>= 9 g/L * Platelets \>= 100,000/mcL * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) * However, patients with known Gilbert disease who have serum bilirubin level of up to 3 mg/dl may b

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