265 Participants NeededMy employer runs this trial

REGN15505 Combinations for Prostate and Kidney Cancers

Recruiting at 4 trial locations
CT
Overseen ByClinical Trials Administrator
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Regeneron Pharmaceuticals
Must be taking: LHRH agonist or antagonist
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new cancer drug, REGN15505, to evaluate its effectiveness alone and in combination with other drugs for treating advanced prostate and kidney cancers. The goal is to discover new methods to enhance the immune system's ability to combat these cancers. The trial will assess side effects, treatment efficacy, and optimal dosing. Men with prostate cancer that has spread and progressed despite treatment, and individuals with clear-cell type kidney cancer that has spread and not responded to previous treatments, may qualify for participation. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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

Previous studies have collected safety information for the drugs tested in this trial. Research shows that REGN15505 is being carefully monitored for side effects when used alone or with other drugs. Some studies have examined its tolerability, but detailed safety results are still being gathered.

Cemiplimab, combined with REGN15505 in one part of the trial, has been used in other studies. These studies often examine how the body processes the drug and any potential side effects. For example, earlier trials of cemiplimab combined with other drugs showed no severe immune-related side effects in some patients who did not respond to treatment.

For the combination of REGN15505 and REGN4336, studies have focused on REGN4336 alone, examining its safety and efficacy. The exact side effects are still under evaluation, but ongoing research aims to learn more about its safety.

As this trial is in the early stages, it primarily focuses on assessing the safety and optimal doses of these drug combinations. Researchers are still learning about side effects and patient responses to the treatments.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments involving REGN15505 for prostate and kidney cancers because they introduce novel combinations and mechanisms that differ from current options like hormone therapy and chemotherapy. REGN15505 alone acts as a monotherapy, targeting specific cancer pathways directly. In combination with Cemiplimab, it leverages an immune checkpoint inhibitor to enhance the immune response against cancer cells. The pairing with REGN4336 brings together two novel agents that may work synergistically to inhibit tumor growth more effectively. These innovative approaches have the potential to offer more targeted and effective treatment options compared to traditional therapies.

What evidence suggests that this trial's treatments could be effective for prostate and kidney cancers?

Research has shown that REGN15505 helps the body's immune cells locate and destroy cancer cells by connecting with specific proteins on the cancer cells' surface. In this trial, some participants may receive REGN15505 alone, which has shown potential to activate the immune system against cancer. Another group will receive a combination of REGN15505 and REGN4336, which demonstrated strong anti-cancer effects in lab tests. Additionally, some participants will receive REGN15505 with cemiplimab, as cemiplimab is known to enhance the immune system's ability to fight cancer. While these findings are promising, more research is needed to fully understand the effectiveness of these treatments in people.36789

Who Is on the Research Team?

CT

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults with advanced prostate cancer (mCRPC) that has worsened after at least two prior treatments, or adults with metastatic clear cell kidney cancer (ccRCC) that has progressed after at least one treatment including immunotherapy and/or targeted therapy. Participants must have measurable disease and meet certain hormone requirements.

Inclusion Criteria

I am a man diagnosed with prostate adenocarcinoma, not pure small cell type.
My prostate cancer has spread and my PSA is 4 ng/mL or higher, with recent progression.
I meet the main requirements for this study.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive REGN15505 alone or in combination with cemiplimab or REGN4336 to evaluate side effects, efficacy, and optimal dosing

Up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cemiplimab
  • REGN15505
  • REGN4336

Trial Overview

The study tests a new drug, REGN15505, given alone or combined with cemiplimab or another drug called REGN4336. The goal is to see how safe these combinations are, what side effects they cause, how well they work against the cancers, and to find the best dose.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Module 3: Combination 2Experimental Treatment1 Intervention
Group II: Module 2: Combination 1Experimental Treatment1 Intervention
Group III: Module 1: MonotherapyExperimental Treatment1 Intervention

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
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Citations

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40404535/

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