CBX-12 for Colorectal Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: CYP3A4/1A2 inducers, inhibitors

Disqualifiers: Pregnancy, Uncontrolled illness, Allergies, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 32

Duration: 21-day cycles, repeated

35 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well CBX-12 works in treating patients with microsatellite stable colorectal cancer that has spread to other parts of the body (metastatic) and is no longer responding to chemotherapy treatment (chemotherapy-refractory). The usual approach to treating colorectal cancer includes treatment with surgery, radiation, or Food and Drug Administration (FDA)-approved drugs such as trifluridine-tipiracil, bevacizumab, regorafenib, or fruquintinib. However, most metastatic colorectal patients progress through all approved treatments and eventually succumb to their disease. CBX-12 is a drug that contains a peptide (a substance that contains many amino acids \[molecules that join together to form proteins\]) called pHLIP, linked to an anticancer substance called exatecan. Upon administration, pHLIP gets inserted into the cellular membrane of tumor cells, delivering exatecan to kill them. Giving CBX-12 may work better than the usual approach in treating patients with metastatic chemotherapy-refractory microsatellite stable colorectal cancer.

Research Team

Chaoyuan Kuang

Principal Investigator

UPMC Hillman Cancer Center LAO

Eligibility Criteria

This trial is for adults with metastatic colorectal cancer that's stable on a microsatellite level and hasn't responded to chemotherapy. They must have enough white blood cells, measurable disease, and be recovered from previous treatments' side effects. Patients should have tried all standard therapies including specific inhibitors based on their cancer type.

Inclusion Criteria

My colorectal cancer is confirmed to be metastatic and has normal mismatch repair function.

My hepatitis B virus load is undetectable with treatment.

I have at least one tumor that can be measured.

Exclusion Criteria

I have recovered from side effects of previous cancer treatments, except for hair loss.

Patients who are receiving any other investigational agents

History of allergic reactions attributed to compounds of similar chemical or biologic composition to CBX-12

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive CBX-12 intravenously over 60 minutes on day 1 of each 21-day cycle

21-day cycles, repeated

1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

12 months

Follow-up at 30 days, then every 3 months

Treatment Details

Interventions

• CBX-12

Trial Overview The trial tests CBX-12, which combines pHLIP (a peptide) with exatecan (an anticancer agent), aiming to target and kill tumor cells more effectively than current treatments. It's for those whose colorectal cancer has spread and resisted chemotherapy.

Participant Groups

Group I: Treatment (CBX-12) Experimental Treatment 6 Interventions

Patients receive CXB-12 IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo x-rays during screening, biopsy during screening and on study, and CT, MRI, and blood collection throughout the study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+