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

StatusRecruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years later Oct 15, 2026 → Oct 15, 2028
See other at-risk trials from National Cancer Institute (NCI)

Record History

The 50 most recent of 62 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Oct 15, 2026 to Oct 15, 2028
    • Primary endpoints: details revised at 2 of 2 entries
    • Eligibility criteria expanded, about 25 words
  2. 42 versions Re-verified since Feb 12, 2026, no change to tracked fieldsv20-v61
  3. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v19
  4. Trial status: Suspended to Active, Not Recruitingv18
  5. Trial status: Active, Not Recruiting to Suspended Sponsor's reason: Drug Supply Issuesv17
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  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v16
  2. 2 versions Re-verified since Jun 13, 2025, no change to tracked fieldsv14-v15
  3. Interventions: Biopsy (Procedure), Biospecimen Collection (Procedure), Computed Tomography (Procedure), pH Low Insertion Peptide-exatecan Conjugate CBX-12… to Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Computed Tomography (Procedure), pH Low Insertion Peptide-exatecan…v13
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05691517
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
Related terms Neoplasm Metastasis
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov