CBX-12 for Colorectal Cancer

No longer recruiting at 16 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, CBX-12, to determine if it outperforms current treatments for metastatic colorectal cancer that has stopped responding to chemotherapy. CBX-12 delivers a cancer-fighting substance directly into cancer cells and may benefit those who have tried at least two other treatments without success. The trial seeks participants with colorectal cancer unresponsive to standard treatments and stable microsatellite regions in their cancer cells. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial does not clearly state if you need to stop your current medications, but it does mention that you cannot take medications that might interact with CBX-12. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that CBX-12 is likely to be safe for humans?

Research has shown that CBX-12 is generally safe for humans. It has been tested in various solid tumors, such as colorectal cancer, and has produced promising results with few side effects. Notably, no serious lung or eye problems were reported, which are concerns with some cancer treatments. Additionally, there were no major issues with the stomach or intestines. These findings suggest that CBX-12 could be a safe option for individuals with advanced cancer, including those in this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

CBX-12 is unique because it targets colorectal cancer with a novel mechanism of action that differs from traditional chemotherapy options like FOLFOX or FOLFIRI. Instead of broadly attacking all rapidly dividing cells, CBX-12 is designed to deliver its effects directly to cancer cells, potentially reducing damage to healthy cells and minimizing side effects. Researchers are excited about this treatment because it offers a more targeted approach, which could lead to better outcomes and improved quality of life for patients with colorectal cancer.

What evidence suggests that CBX-12 might be an effective treatment for metastatic colorectal cancer?

Research has shown that CBX-12, the treatment under study in this trial, may help treat advanced or spreading solid tumors, such as colorectal cancer. Earlier studies found CBX-12 to be safe and effective in delivering more of the cancer-fighting drug exatecan directly to cancer cells, sparing normal cells. Early results showed positive effects in various cancers, including one confirmed case in colorectal cancer. This suggests CBX-12 might benefit patients whose cancer hasn't responded to other treatments. By targeting cancer cells directly, CBX-12 could offer new hope for those with advanced cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Chaoyuan Kuang

Principal Investigator

UPMC Hillman Cancer Center LAO

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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, and CT, MRI, and blood collection throughout the study and patients may undergo biopsy during screening and on study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06730100

Study Details | NCT06730100 | CBX-12 for the Treatment ... Giving CBX-12 may work better than the usual approach in treating patients with metastatic chemotherapy-refractory microsatellite stable colorectal cancer.

2. cybrexa.com cybrexa.com/press-release/cybrexa-therapeutics-announces-positive-final-data-at-esmo-2024-from-phase-1-study-of-peptide-drug-conjugate-cbx-12-in-advanced-solid-tumors/

Data demonstrate broad activity of CBX-12 ... These data demonstrate that CBX-12 is well tolerated and exhibits promising activity across a range of advanced or metastatic solid tumors.

3. onclive.com onclive.com/view/early-data-signal-response-with-cbx-12-in-advanced-or-metastatic-solid-tumors

Early Data Signal Response With CBX-12 in Advanced or ... [With CBX-12], preclinical studies have shown that we can deliver more exatecan into the cancer cells than into the normal cells. We still did ...

4. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)02254-3/pdf

669P CBX-12-101 There were 5 confirmed responses in ovarian (2), breast (2), and colorectal cancer (1). Evidence of activity was also seen in NSCLC, cholangiocarcinoma, and ...

5. cybrexa.com cybrexa.com/wp-content/uploads/2024/09/ESMO2024.pdf

Final Results of a Phase 1 Study of CBX-12, a Peptide ... CBX-12 has broad activity, particularly in TOP1 naïve patients with a response rate in ovarian cancer of 40% and breast cancer of 43%. • CBX-12 had a ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-10048

CBX-12 for the Treatment of Metastatic Chemotherapy ... 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 ...

7. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)02254-3/fulltext

Final results of a phase I study of CBX-12, a peptide drug ... No ILD or ophthalmic toxicity was reported. There were 5 confirmed responses in ovarian (2), breast (2), and colorectal cancer (1). Evidence of activity was ...

8. targetedonc.com targetedonc.com/view/cbx-12-shows-antitumor-activity-and-safety-in-solid-tumors

CBX-12 Shows Antitumor Activity and Safety in Solid Tumors “In this phase 1 study, CBX-12 demonstrated safety and tolerability, without significant gastrointestinal toxicity. We also saw signal of ...