CBX-12 for Advanced Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: QT prolonging, CYP3A4 inhibitors

Disqualifiers: Pregnancy, Uncontrolled illness, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: Up to 2 years

35 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that certain medications that affect CBX-12 or prolong the QT interval may require you to switch to alternatives. It's best to discuss your current medications with the trial team to see if any changes are needed.

Research Team

Alice P Chen

Principal Investigator

National Cancer Institute LAO

Eligibility Criteria

This trial is for adults over 18 with advanced solid tumors that have spread and worsened after at least one prior treatment. They should be relatively active (able to care for themselves), have certain blood cell counts within a safe range, and have tumors measurable by scans or visible during an exam. A tumor site must also be accessible for biopsy.

Inclusion Criteria

Magnesium ≥ LLN

Oxygen (O2) saturation > 90% on room air

Willingness to provide biopsy samples for research purposes

Exclusion Criteria

Patients who are receiving any other investigational agents

I do not have any severe illnesses that would stop me from following the study's requirements.

I have recovered from major side effects of my last cancer treatment, except for hair loss or low lymphocyte count.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CBX-12 intravenously over 60 minutes on days 1, 8, 15, and 22 of each 28-day cycle. Tumor biopsies, CT scans, and blood sample collections are conducted throughout the trial.

Up to 2 years

4 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• CBX-12

Trial Overview The trial is testing CBX-12, which targets the TOP1 protein inside cancer cells to damage their DNA and cause cell death. It's being studied in patients with advanced cancers to see if it's more effective than current treatments.

Participant Groups

Group I: Treatment (CBX-12) Experimental Treatment 4 Interventions

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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+