REGN6569 + Cemiplimab for Advanced Solid Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment combination for advanced solid cancers. Researchers aim to determine the safest dose of an experimental drug, REGN6569, when used with cemiplimab, and to assess whether this combination can shrink tumors. The study also examines how these drugs interact in the body and any potential side effects. It suits individuals with advanced solid tumors who have not responded to other treatments. Participants must provide tumor samples for research. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I need to stop my current medications to join the trial?
The trial protocol does not clearly specify if you need to stop taking your current medications. However, you cannot participate if you have received certain biologic therapies recently or if you require ongoing corticosteroid treatment above a certain dose.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that cemiplimab, a treatment approved by the FDA for certain cancers, is generally safe. In studies involving patients with advanced non-small cell lung cancer, most tolerated cemiplimab well, with manageable side effects.
For REGN6569, human studies are still in the early stages. These studies aim to determine the safest dose when combined with cemiplimab. So far, REGN6569 has been administered to patients with various solid tumors, and the combination has been mostly well-tolerated. Researchers continue to work on identifying the optimal dose.
Both treatments undergo careful testing to ensure safety. While cemiplimab has more established safety data, REGN6569 remains under study. Trial participants receive close monitoring to manage any potential side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about REGN6569 combined with cemiplimab for advanced solid cancers because it represents a novel approach to treatment. Unlike traditional chemotherapy or radiation, which can affect healthy cells along with cancerous ones, this combination includes a targeted therapy. Cemiplimab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells more effectively. The addition of REGN6569 is believed to enhance this effect by further modulating the immune response. This dual-action strategy aims to provide a more precise and potentially more effective treatment option for patients with advanced cancers.
What evidence suggests that REGN6569 and cemiplimab could be effective for advanced solid cancer?
Research has shown that cemiplimab, when combined with other treatments, can significantly improve survival rates for certain cancers, such as squamous non-small cell lung cancer. Cemiplimab aids the immune system in fighting cancer by blocking a protein that typically prevents the immune system from attacking cancer cells. In this trial, participants will receive REGN6569, designed to reduce the number of Treg cells, which are immune cells that can protect tumors. Together, REGN6569 and cemiplimab aim to strengthen the immune system and directly target cancer cells. Early studies suggest that this combination could shrink tumors by enhancing the body's natural defenses.16789
Who Is on the Research Team?
Clinical Trial Management
Principal Investigator
Regeneron Pharmaceuticals
Are You a Good Fit for This Trial?
Adults with advanced solid tumors, specifically those with unresectable or metastatic head and neck squamous cell carcinoma who haven't had immune checkpoint blockade therapy, have exhausted all treatment options, and can provide tumor tissue for biopsies. Excluded are those on recent systemic biologics or continuous steroids, with significant autoimmune disease, recent live vaccines (including COVID-19 vaccine within certain time frames), organ transplants, prior GITR-targeted therapy, interstitial lung disease/pneumonitis history, or uncontrolled HIV/Hepatitis.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive REGN6569 with cemiplimab to find the highest safe dose and assess side effects
Dose Expansion
Participants are randomized to receive either concurrent REGN6569 + cemiplimab or REGN6569 lead-in followed by combo therapy to evaluate efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cemiplimab
- REGN6569
Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
- Basal cell carcinoma (BCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
- Cutaneous squamous cell carcinoma (CSCC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Regeneron Pharmaceuticals
Lead Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School