Pidnarulex + Cemiplimab for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the combination of two treatments, pidnarulex and cemiplimab, to determine their effectiveness in treating colorectal cancer that has not responded to other treatments. Pidnarulex aims to stop tumor growth by blocking certain enzymes, while cemiplimab, an immunotherapy drug, helps the immune system attack the cancer. Individuals with metastatic colorectal cancer that does not respond to standard treatments might be suitable candidates, especially if they have not had success with medications like irinotecan or bevacizumab. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.
Do I have to stop taking my current medications for the trial?
The trial requires a 28-day period without taking epidermal growth factor receptor (EGFR) inhibitors like cetuximab and panitumumab before starting. If you're on strong CYP3A4 inhibitors or inducers, you may need to stop those as well. 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 this trial's treatments are likely to be safe?
Previous studies have shown that cemiplimab is generally well-tolerated by patients. When combined with chemotherapy, many patients experienced long-term survival benefits with manageable side effects. The most common side effects included tiredness and skin rash, typically mild.
Research has shown that pidnarulex, also known as CX-5461, is effective against tumors in various cancer types. However, there is concern that it might cause cellular changes, potentially increasing the risk of developing another cancer. More research is needed to fully understand its safety.
The combination of pidnarulex with cemiplimab remains under study. Early research suggests it might be safe and effective, but further trials are necessary to confirm this. Participants in these trials have demonstrated that the treatment can be tolerated, although the full range of possible side effects is still being explored.12345Why are researchers excited about this trial's treatments?
Unlike the usual treatments for colorectal cancer, which often include chemotherapy and targeted therapies like bevacizumab or cetuximab, the combination of Pidnarulex and Cemiplimab offers a fresh approach. Pidnarulex is designed to disrupt cancer cell DNA repair mechanisms, potentially leading to more effective cancer cell death. Cemiplimab, on the other hand, is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells. Researchers are excited because this combination could enhance the body's natural defenses while directly targeting cancer cell survival tactics, offering a potentially more comprehensive attack on the cancer.
What evidence suggests that this trial's treatments could be effective for refractory MSS colorectal cancer?
Research has shown that pidnarulex targets enzymes essential for cancer cell growth, potentially stopping tumor progression. It has effectively treated various solid tumors with specific genetic issues. Cemiplimab, an immunotherapy, enhances the immune system's ability to fight cancer and has improved survival rates in some patients, demonstrating a strong response rate. In this trial, some participants will receive pidnarulex alone, while others will receive a combination of cemiplimab and pidnarulex. This combination might enhance effectiveness against refractory MSS colorectal cancer, which standard methods struggle to treat. Early findings suggest this combination could offer a promising new approach.13456
Who Is on the Research Team?
Wells A Messersmith
Principal Investigator
JHU Sidney Kimmel Comprehensive Cancer Center LAO
Are You a Good Fit for This Trial?
This trial is for adults (18+) with colorectal cancer that has spread or can't be removed by surgery, and whose cancer did not respond to standard treatments. Participants must have microsatellite stable tumors, certain genetic changes (MYC amplification or FBXW7 mutation), at least one liver metastasis, and be well enough to do daily activities.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Patients receive cemiplimab IV over 30 minutes on days 1 and 15 and pidnarulex IV over 60 minutes on days 1 and 8 of each cycle. Cycles repeat every 28 days for up to 26 cycles.
Phase II Treatment
Patients are randomized to receive either pidnarulex alone or in combination with cemiplimab. Cycles repeat every 28 days for up to 26 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs at 30 days post-treatment and then every 3 months for 2 years.
What Are the Treatments Tested in This Trial?
Interventions
- Cemiplimab
- Pidnarulex
Trial Overview
The study is testing a combination of two anti-cancer drugs—Pidnarulex and Cemiplimab—to find the best dose and see how well they work together in people with hard-to-treat colorectal cancer. Imaging scans and biopsies are also part of the study.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Patients receive cemiplimab IV over 30 minutes on days 1 and 15 of each cycle and pidnarulex IV over 60 minutes on days 1 and 8 of each cycle. Cycles repeat every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo tumor biopsy and CT, MRI, or PET/CT throughout the trial. Additionally, patients undergo blood sample collection on study.
Patients receive cemiplimab IV over 30 minutes on days 1 and 15 of each cycle and pidnarulex IV over 60 minutes on days 1 and 8 of each cycle. Cycles repeat every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection on study and CT, MRI, or PET/CT throughout the trial.
Patients receive pidnarulex IV over 60 minutes on days 1 and 8 of each cycle. Cycles repeat every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo tumor biopsy and CT, MRI, or PET/CT throughout the trial. Additionally, patients undergo blood sample collection on study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
Study Details | NCT07147231 | Testing the Effectiveness of ...
Giving pidnarulex with cemiplimab may be safe, tolerable and/or effective in treating patients with refractory MSS CRC. Detailed Description. PRIMARY OBJECTIVES ...
Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX ...
This phase I/II trial studies the side effects and best dose of pidnarulex when given together with cemiplimab and to see how well it works in treating ...
A G-quadruplex stabilizer, CX-5461 combined with two ... - PMC
Immune checkpoint inhibitors (ICIs) alone or in combination with chemotherapy can improve the limited efficacy of colorectal cancer (CRC) ...
Testing the Effectiveness of the Anti-cancer Drug ...
This phase I/II trial studies the side effects and best dose of pidnarulex when given together with cemiplimab and to see how well it works in treating ...
Pidnarulex: Uses, Side Effects, Dosing & 5 Clinical Trials
This trial is evaluating Pidnarulex in combination with cemiplimab (REGN2810) for patients with refractory microsatellite stable colorectal ...
Safety, efficacy, and quality of life with cemiplimab treatment ...
Cemiplimab can be used as monotherapy or in combination with chemotherapy for both squamous and non-squamous cancers. We opted for a systematic ...
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