REGN10597 for Solid Tumors

Recruiting at 14 trial locations

Overseen By Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Regeneron Pharmaceuticals

Must not be taking: Interleukins, PD-1/PD-L1, Corticosteroids, others

Disqualifiers: Autoimmune disease, Allergy, others

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

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an experimental drug, REGN10597, to determine its safety and effectiveness for individuals with advanced solid tumors. Researchers aim to identify potential side effects, understand how the drug moves through the body, and assess any immune reactions. The trial consists of two parts: one to determine the appropriate dose and another to test the drug on individuals with melanoma or a type of kidney cancer. Individuals whose solid tumors have worsened despite other treatments might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have had certain treatments recently, like specific cancer therapies or ongoing corticosteroid use. It's best to discuss your current medications with the trial team to see if they might affect your eligibility.

Is there any evidence suggesting that REGN10597 is likely to be safe for humans?

Research has shown that REGN10597 is currently being tested for safety in humans. Since these are early studies, limited information is available. The main goal is to assess how well participants tolerate the treatment and identify any potential side effects.

In this early trial stage, the focus is on evaluating drug tolerance and detecting harmful effects. Researchers closely monitor participants for any negative reactions. As this is the first human trial of the drug, its safety and effectiveness remain unproven.

For those considering joining a trial with REGN10597, it's important to know that while no major safety issues have been reported so far, researchers are still gathering information about this treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about REGN10597 because it has a unique approach in treating solid tumors. Unlike other treatments that typically target tumor growth through traditional chemotherapy or radiation, REGN10597 works by a novel mechanism, potentially targeting specific pathways involved in tumor development and progression. This could mean more effective treatment with fewer side effects. Additionally, by identifying the optimal dose in Phase 1 and focusing on specific cancers like melanoma and clear-cell renal-cell carcinoma in Phase 2, it offers a more tailored treatment strategy. This targeted approach could lead to improved outcomes for patients who currently have limited options.

What evidence suggests that REGN10597 might be an effective treatment for solid tumors?

Research has shown that REGN10597 may help fight certain advanced solid tumors. In animal studies, it demonstrated strong activity against various cancers, such as melanoma and prostate cancer. This suggests the drug might enhance the immune system's ability to locate and destroy cancer cells. Although human studies have provided limited information, these early results justify further research. In this trial, participants will receive REGN10597 in different phases, including a dose escalation phase to identify the recommended Phase 2 dose, followed by a dose expansion phase for specific cancer types like melanoma and clear-cell renal-cell carcinoma. The drug's potential to work with the body's immune system is a key reason for testing it against these challenging cancer types. ^{1 3 5 6 7}

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, including melanoma and kidney cancers, who have seen their cancer progress despite standard treatments. They must provide a fresh biopsy before treatment and may need to submit previous tissue samples.

Inclusion Criteria

My cancer is advanced or has spread, and it's getting worse despite treatment.

I can provide samples of my cancer tissue for the study.

My cancer is confirmed as melanoma or kidney cancer through a lab test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Multiple dose level cohorts to identify the recommended Phase 2 dose (RP2D)

Approximately 6 years

Dose Expansion

Cohort 1: Melanoma Participants, Cohort 2: Clear-cell renal-cell carcinoma (ccRCC) participants

Approximately 6 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• REGN10597

Trial Overview The trial is testing REGN10597, an experimental drug for advanced solid tumors. It aims to determine the drug's safety, tolerability, effectiveness, how it circulates in the blood over time, and if the body develops antibodies against it.

How Is the Trial Designed?

Group I: Phase 2: Dose Expansion Experimental Treatment 1 Intervention

Cohort 1: Melanoma Participants Cohort 2: Clear-cell renal-cell carcinoma (ccRCC) participants

Group II: Phase 1: Dose Escalation Experimental Treatment 1 Intervention

Multiple dose level (DL) Cohorts to identify the recommended Phase 2 dose (RP2D)

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

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

Published Research Related to This Trial

Regorafenib is an effective oral tyrosine kinase inhibitor approved for treating refractory metastatic colorectal cancer, advanced gastrointestinal stromal tumors, and unresectable hepatocellular carcinoma, with its efficacy supported by phase 3 trials like CORRECT, CONCUR, GRID, and RESORCE.

The review highlights the need for managing drug-related toxicities through dose optimization and emphasizes ongoing research into biomarkers that could predict patient responses to regorafenib, as well as its potential effectiveness in other cancer types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving role of regorafenib for the treatment of advanced cancers. Grothey, A., Blay, JY., Pavlakis, N., et al.[2020]

In a phase II trial involving 48 patients with microsatellite stable colorectal cancer, the combination of regorafenib and avelumab showed a best response of stable disease in 53.5% of patients, with a median progression-free survival of 3.6 months and overall survival of 10.8 months.

The study found that higher infiltration of CD8+ T cells in tumors was linked to better outcomes, suggesting that assessing immune cell presence could help identify patients who might benefit more from this treatment combination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regorafenib-Avelumab Combination in Patients with Microsatellite Stable Colorectal Cancer (REGOMUNE): A Single-arm, Open-label, Phase II Trial. Cousin, S., Cantarel, C., Guegan, JP., et al.[2022]

Regorafenib is an effective multikinase inhibitor that targets various tyrosine kinases involved in cancer, leading to its approval as a second-line treatment for advanced hepatocellular carcinoma (HCC) and a third-line treatment for colorectal cancer (CRC) and gastrointestinal stromal tumors (GISTs).

Research indicates that while regorafenib shows beneficial effects in treating these cancers, there is a potential loss of sensitivity in tumor cells, prompting investigations into combining regorafenib with other therapies to enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-tumoral activity of single and combined regorafenib treatments in preclinical models of liver and gastrointestinal cancers. Fondevila, F., Méndez-Blanco, C., Fernández-Palanca, P., et al.[2022]

Regorafenib shows promising efficacy in gastric and colorectal cancer cells, particularly in those with amplification of the fibroblast growth factor receptor 2 (FGFR2), which is linked to sensitivity to the drug.

In preclinical models, regorafenib effectively inhibited FGFR2 signaling and induced cell cycle arrest and apoptosis in FGFR2-amplified cancer cells, suggesting it could be a targeted treatment option for patients with this specific genetic alteration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FGFR2 amplification is predictive of sensitivity to regorafenib in gastric and colorectal cancers in vitro. Cha, Y., Kim, HP., Lim, Y., et al.[2022]

In a study of 138 metastatic colorectal cancer patients treated with regorafenib, the VEGF-A gene polymorphism rs2010963 was found to independently correlate with both progression-free survival (PFS) and overall survival (OS), suggesting its potential as a predictive biomarker for treatment outcomes.

The research indicates that genotyping for VEGF-A rs2010963 could help identify which patients are more likely to benefit from regorafenib therapy, allowing for better patient stratification into favorable, intermediate, and unfavorable prognostic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Angiogenesis genotyping and clinical outcome during regorafenib treatment in metastatic colorectal cancer patients. Giampieri, R., Salvatore, L., Del Prete, M., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06413680

Study Details | NCT06413680 | A First-In Human (FIH) Trial ... This study is researching an experimental drug called REGN10597 (called "study drug"). The study is focused on patients with certain solid tumors that are ...

2. clinicaltrials.regeneron.com clinicaltrials.regeneron.com/clinical-trials/a0MPr000000NOfxMAG/nct06413680

A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe ... The study is focused on patients with certain solid tumors that are in an advanced stage. The aim of the study is to see how safe, tolerable, and effective the ...

3. withpower.com withpower.com/trial/regn10597-for-solid-tumors-92e7d

REGN10597 for Solid Tumors This Phase 1 & 2 medical study run by Regeneron Pharmaceuticals is evaluating whether REGN10597 will have tolerable side effects & efficacy for patients ...

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/renal-cell-carcinoma

Renal Cell Carcinoma clinical trials at UCSF First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2095927325008096

Synergistic potential of PD-1 blockade and IL-2 in cancer ... REGN10597 exhibits robust anti-tumor activity across various syngeneic murine tumor models, including B16F10 melanoma, MCA205 fibrosarcoma, TRAMP-C2 prostate ...

6. careacross.com careacross.com/clinical-trials/trial/NCT06413680

A FirstIn Human FIH Trial to Find Out if REGN10597 is Safe ... A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies. To hear about ...

7. regeneron.com regeneron.com/science/investigational-pipeline

Regeneron Pipeline & Medicines in Development The safety and efficacy of these drug candidates have not been fully evaluated by any regulatory authority for the indications described in this section ...