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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, CBX-12 (also known as alphalex™-exatecan), for individuals with advanced or metastatic cancer. The goal is to evaluate how effectively CBX-12 targets a specific protein inside cancer cells, damaging their DNA and killing them. Participants should have solid tumors that have spread and have not responded to at least one prior treatment. Those with such conditions who can provide a biopsy sample may qualify for this trial. Participants will receive CBX-12 intravenously and undergo regular scans and blood tests to monitor progress. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering the chance to be among the first to receive this innovative therapy.

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.

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

Research shows that CBX-12 is generally safe for people with advanced or spreading solid tumors. Earlier studies found that those taking CBX-12 experienced few serious side effects. In these studies, CBX-12 also slowed tumor growth. This suggests that CBX-12 might be a safe treatment option for advanced cancers. However, as this is a Phase 1 trial, researchers continue to learn about its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for advanced cancer, which often include chemotherapy or targeted therapies, CBX-12 offers a new approach by being administered intravenously in a precise, timed manner over 28-day cycles. This drug stands out because it is designed to minimize toxicity while maximizing the attack on cancer cells. Researchers are excited about CBX-12 because it has the potential to provide an effective treatment with fewer side effects, thanks to its targeted delivery mechanism, allowing it to hone in on cancer cells without harming healthy ones. This could lead to better patient outcomes and improved quality of life during treatment.

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

Research has shown that CBX-12, the treatment under study in this trial, holds promise for treating advanced or spreading solid tumors. Studies have found that CBX-12 is generally safe and effective for various cancer types. Notably, one study reported a strong response rate of 40% in ovarian cancer patients who had not received similar treatments before. CBX-12 targets and damages the DNA of cancer cells, causing them to die. These findings suggest that CBX-12 could be a powerful option for combating advanced cancers. ^{1 3 4 5 6}

Who Is on the Research Team?

Alice P Chen

Principal Investigator

National Cancer Institute LAO

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. 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 ... Data demonstrate broad activity of CBX-12 across six tumor types with a strong response rate in TOP1-naïve patients with ovarian (40%; N=10) ...

2. synapse.patsnap.com synapse.patsnap.com/article/cybrexa-therapeutics-reports-positive-final-data-on-cbx-12-phase-1-study-at-esmo-2024

Cybrexa Therapeutics Reports Positive Final Data on CBX- ... The data revealed that CBX-12 is well tolerated and shows significant efficacy across different types of advanced or metastatic solid tumors, ...

3. cybrexa.com cybrexa.com/press-release/

Press Releases Archive - Cybrexa ... ... CBX-12 (alphalex™ exatecan). These data demonstrate that CBX-12 is well tolerated and exhibits promising activity across a range of advanced or metastatic ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36597724/

Antigen-independent tumor targeting by CBX-12 (alphalex CBX-12 combined with anti-PD-1 or anti-CTLA4 results in delayed tumor growth and complete response, with cured animals displaying long-term antitumor immunity.

5. finance.yahoo.com finance.yahoo.com/news/cybrexa-therapeutics-announces-positive-final-103000278.html

Cybrexa Therapeutics Announces Positive Final Data at ... Data demonstrate broad activity of CBX-12 across six tumor types with a strong response rate in TOP1-naïve patients with ovarian (40%; N=10) ...

6. 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 a first-in-human trial, a peptide-drug conjugate showed tolerability and antitumor activity in patients with advanced solid tumors.