Apply to Trial

Compensation: Varies

Number of Visits: Unknown

38 Participants Needed

REGN6569 + Cemiplimab for Advanced Solid Cancer

Recruiting at 15 trial locations

Overseen ByClinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Regeneron Pharmaceuticals

Must not be taking: Corticosteroids, Biologics, Immunosuppressants, others

Disqualifiers: Autoimmune disease, Lung disease, HIV, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

There are two main goals of this study: The first is to find the highest safe dose of REGN6569 when given with cemiplimab. The second is to get some initial information about how well the REGN6569 in combination with cemiplimab may help shrink certain types of cancer. The study is also looking at: * Side effects that may be experienced by people taking REGN6569 alone and with cemiplimab * How REGN6569 and cemiplimab work in the body * How much REGN6569 and cemiplimab is in your blood * To see if REGN6569 can lower the number of Treg cells in tumors * To see if REGN6569 and cemiplimab can shrink tumors when given together

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

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

I can provide tissue samples from my cancer before and during treatment.

My cancer is an advanced head and neck cancer that cannot be surgically removed.

My cancer is in an advanced stage and cannot be removed by surgery.

See 2 more

Exclusion Criteria

I've been on more than 10 mg of prednisone or equivalent daily for the last 2 weeks.

I have had a stem cell or organ transplant.

I haven't taken any biologic therapy recently as per the study's timeline.

See 5 more

Treatment Details

Interventions

Cemiplimab
REGN6569

Trial OverviewThe trial is testing REGN6569 alone and in combination with cemiplimab to evaluate safety and tolerability initially. It aims to measure the effectiveness of this combo by looking at response rates and survival outcomes in patients. The study will also examine how the body processes these drugs and their potential to provoke an immune response.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment2 Interventions

Randomized 1:1 between cohorts Cohort 1: Concurrent start of REGN6569 + cemiplimab Cohort 2: REGN6569 lead-in, then combo therapy

Group II: Dose EscalationExperimental Treatment2 Interventions

REGN6569 lead-in, then combo therapy

Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:

Approved in European Union as Libtayo for:

Cutaneous squamous cell carcinoma (CSCC)
Non-small cell lung cancer (NSCLC)

Approved in United States as Libtayo for:

Cutaneous squamous cell carcinoma (CSCC)
Basal cell carcinoma (BCC)
Non-small cell lung cancer (NSCLC)

Approved in Canada as Libtayo for:

Cutaneous squamous cell carcinoma (CSCC)
Non-small cell lung cancer (NSCLC)

Approved in Brazil as Libtayo for:

Cutaneous squamous cell carcinoma (CSCC)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Other People Viewed

By Subject

By Trial