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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05691517
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Malignant Solid Neoplasm
  • Metastatic Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • pH Low Insertion Peptide-exatecan Conjugate CBX-12 — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Jun 12, 2024
Status verified
Feb 2026
Primary completion
Oct 15, 2026
Completion
Oct 15, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (CBX-12)
    Aatients receive CBX-12 IV, over 60 minutes, on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy and CT scans on study and undergo blood sample collection throughout the trial.

Primary Outcome Measure

Early Rad51/deoxyribonucleic acid (DNA) damage response (DDR) [ Time Frame: At cycle 1 day 2 (1 cycle = 28 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Cancer Institute Developmental Therapeutics ClinicBethesdaMaryland20892
Site Public Contact
800-411-1222
A P. Chen (PRINCIPAL_INVESTIGATOR)

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By research site
National Cancer Institute Developmental Therapeutics Clinic· Bethesda, MD

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