DCSZ11 + Radiation + Chemotherapy for Rectal Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must not be taking: Monoclonal antibodies, Antineoplastics

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

Stay on Your Current Meds You can continue your current medications while participating

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: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called DCSZ11, combined with radiation and chemotherapy, for certain types of rectal cancer. The researchers aim to assess the safety and effectiveness of this combination for treating locally advanced rectal cancer that is mismatch repair proficient, a type of genetic stability. Individuals with rectal cancer exhibiting specific tumor characteristics who have not received prior treatment may qualify for this study. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, you must not have received any prior systemic treatment or radiation for your cancer, and you cannot be expected to require any other form of cancer therapy while on the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that DCSZ11 has undergone safety testing. One study found no safety issues when DCSZ11 was used alone or with other treatments, indicating that the treatment is generally well-tolerated. However, further research is necessary to confirm these results in larger groups. While these early findings are promising, they should be approached with caution. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for rectal cancer?

Unlike the standard treatments for rectal cancer, which typically involve surgery, chemotherapy, and radiation, DCSZ11 stands out for its novel approach. This treatment is unique because it combines with chemotherapy to potentially enhance the effects of existing therapies. Researchers are particularly excited about DCSZ11 because it targets cancer cells more precisely, which may lead to better outcomes and fewer side effects for patients. This innovative approach could offer a more effective and patient-friendly alternative to current treatment options.

What evidence suggests that this trial's treatments could be effective for rectal cancer?

Research shows that combining treatments can be very effective against cancer. One study demonstrated that using both targeted therapy and immunotherapy together had a strong impact, with 80.6% of patients with advanced metastatic colorectal cancer responding well. This trial will evaluate the effectiveness of combining DCSZ11 with chemotherapy and radiation for rectal cancer. Early research on DCSZ11, whether used alone or with other treatments, has shown promise in treating advanced cancer. Although limited data exists on DCSZ11 specifically for rectal cancer, combining therapies has yielded positive results in similar types of cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Eric Christenson, MD

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medical Institution

Are You a Good Fit for This Trial?

This trial is for adults (18+) with high-risk, locally advanced rectal cancer that has not spread to distant organs. Their cancer must be mismatch repair proficient (pMMR) and they should not have had prior chemo or radiation. Participants need to be in good physical condition.

Inclusion Criteria

I have lymph nodes larger than 10 mm on the side of my body.

My MRI shows cancer has spread to blood vessels outside the organ.

My cancer has not spread to distant parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive short course radiation as part of the neoadjuvant treatment

4-6 weeks

Chemotherapy

Participants receive capecitabine/oxaliplatin (CAPOX) chemotherapy in combination with DCSZ11

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment for complete clinical response

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Capecitabine
• DCSZ11
• Oxaliplatin
• Radiation

Trial Overview

The study tests adding a new drug, DCSZ11, to standard chemotherapy (capecitabine and oxaliplatin) and radiation before surgery for rectal cancer. The goal is to see if this combination is safe and effective.

How Is the Trial Designed?

Group I: DCSZ11 with Chemotherapy Experimental Treatment 4 Interventions

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

DynamiCure Biotechnology

Industry Sponsor

Trials

2

Recruited

260+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07580339

Combining DCSZ11 With Radiation and Chemotherapy as ...

The purpose of this study is to evaluate the safety and clinical activity of combining DCSZ11 with radiation and capecitabine/oxaliplatin (CAPOX) ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2702234/

Efficacy, Safety, and Biomarkers of Neoadjuvant Bevacizumab ...

This treatment resulted in an actuarial 5-year local control and overall survival of 100%. Actuarial 5-year disease-free survival was 75% and five patients ...

3.

australianclinicaltrials.gov.au

australianclinicaltrials.gov.au/anzctr-search-results?condition_category=all&condition_code=all&ethics_approval=Yes&gender=all&healthy_volunteers=all&phase=all&purpose_of_study=all&recruitment_sites=all&recruitment_status=Recruiting&search_text=&page=592

ANZCTR search results | Australian Clinical ...

This is a multicenter, open-label, Phase 1 study to assess the effects of DCSZ11 as a monotherapy and in combination in patients with advanced or metastatic ...

4.

withpower.com

withpower.com/trial/phase-2-rectal-neoplasms-6-2026-d0ae6

DCSZ11 + Radiation + Chemotherapy for Rectal Cancer

The purpose of this study is to evaluate the safety and clinical activity of combining DCSZ11 with radiation and capecitabine/oxaliplatin (CAPOX) for the ...

5.

mayo.edu

mayo.edu/research/clinical-trials/diseases-conditions/cancer

Cancer Clinical Trials

... Colorectal Cancer Rochester, MN. This study will assess the efficacy and outcomes of PD-1 blockade in patients with mismatch repair deficient colorectal cancer.

6.

mayo.edu

mayo.edu/research/clinical-trials/tests-procedures/cancer-treatment

Cancer Treatment Clinical Trials

The purpose of this study is to evaluate the safety, tolerability and effectiveness of CG-806 for the treatment of patients with the condition of chronic ...