REGN10597 for Solid Tumors

Recruiting at 13 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

Trial Summary

What is the purpose of this 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 in an advanced stage. The aim of the study is to see how safe, tolerable, and effective the study drug is. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

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.

What data supports the effectiveness of the drug REGN10597 for solid tumors?

Regorafenib, a drug similar to REGN10597, has shown effectiveness in treating advanced cancers like colorectal cancer and gastrointestinal stromal tumors by improving survival rates in clinical trials. It works by targeting specific proteins involved in cancer growth and blood vessel formation, which may suggest potential benefits for solid tumors. ^{1 2 3 4 5}

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Evolving role of regorafenib for the treatment of advanced cancers. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

FGFR2 amplification is predictive of sensitivity to regorafenib in gastric and colorectal cancers in vitro. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Regorafenib-Avelumab Combination in Patients with Microsatellite Stable Colorectal Cancer (REGOMUNE): A Single-arm, Open-label, Phase II Trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Angiogenesis genotyping and clinical outcome during regorafenib treatment in metastatic colorectal cancer patients. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Anti-tumoral activity of single and combined regorafenib treatments in preclinical models of liver and gastrointestinal cancers. [2022]