What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as targeted therapies, immunotherapies, and chemotherapy, often have a range of side effects. Targeted therapies like regorafenib can cause fatigue, hand-foot skin reactions, hypertension, and diarrhea. Immunotherapies, including drugs like cemiplimab, may lead to immune-related adverse events such as colitis, pneumonitis, hepatitis, and endocrinopathies. Chemotherapy can result in nausea, vomiting, hair loss, myelosuppression, and increased risk of infections. These side effects vary in severity and frequency among patients.

What prior FDA approvals exist?

Several FDA-approved treatments for solid tumors focus on mechanisms similar to those being studied with REGN7075. For instance, immune checkpoint inhibitors like pembrolizumab and nivolumab have been approved for various solid tumors, including melanoma and non-small cell lung cancer, due to their ability to enhance the immune system's response against cancer cells. Additionally, combination therapies such as pembrolizumab with chemotherapy or other targeted agents like cetuximab have shown efficacy in treating head and neck cancers. These treatments aim to control tumor growth and shrink tumors by targeting specific pathways involved in cancer cell proliferation and survival.

What other types of research exist?

Promising novel alternatives to REGN7075 for solid tumor patients in 2024 include: <ol> <li>Cabozantinib: A tyrosine kinase inhibitor that has shown efficacy in various solid tumors, including renal cell carcinoma and medullary thyroid cancer.</li> <li></li> </ol> Pembrolizumab: An immune checkpoint inhibitor that has been effective in treating multiple types of solid tumors, often in combination with other therapies. 3. Regorafenib: A multi-kinase inhibitor that has demonstrated activity in colorectal cancer and osteosarcoma. 4. Lenvatinib: Another multi-kinase inhibitor, often used in combination with other agents like pembrolizumab, showing promise in advanced solid tumors. 5. Sorafenib: A kinase inhibitor with activity in liver, kidney, and thyroid cancers, among others. These alternatives are in various stages of clinical trials and have shown potential in controlling tumor growth and inducing tumor shrinkage.

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Monoclonal Antibodies

REGN7075 + Cemiplimab for Advanced Cancer (COMBINE-EGFR-1 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willing to provide tumor tissue from newly obtained biopsy (at a minimum core biopsy) from a tumor site that has not been previously irradiated

≥18 years of age (≥20 years of age for patients enrolled in Japan)

Must not have

Has any ongoing inflammatory skin disease as defined in the protocol

Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called REGN7075, alone or with other treatments, on patients with advanced solid tumors. The goal is to see if it can stop tumor growth and shrink the tumors.

Who is the study for?

Adults with advanced solid tumors who have never been treated with PD-1/PD-L1 inhibitors, have a measurable lesion, are in good physical condition (ECOG 0 or 1), and can provide a new tumor tissue sample. They must not be on other clinical trials, haven't had certain treatments recently, don't have brain tumors or CNS issues, no significant autoimmune disease requiring immunosuppressants, and no second active cancer.

What is being tested?

The trial is testing REGN7075 alone and combined with cemiplimab plus/minus chemotherapy to determine safety, tolerability, optimal dosing levels for advanced solid tumors treatment effectiveness by observing the control of tumor cell growth and shrinkage.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from the drug administration process itself; fatigue; changes in blood composition that could affect overall health; digestive disturbances; increased susceptibility to infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to provide a new biopsy sample from a tumor that hasn't been treated with radiation.

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I am at least 18 years old, or 20 if I am in Japan.

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I am fully active or can carry out light work.

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My cancer diagnosis has been confirmed by lab tests on tissue or fluid samples.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a current skin condition that causes inflammation.

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I have an untreated brain tumor or cancer that has spread to my brain or spinal cord.

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I have recently been treated with drugs targeting EGFR.

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I have another cancer that is getting worse or needs treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and severity of adverse events of special interest (AESIs)

Incidence and severity of grade ≥3 laboratory abnormalities

Incidence and severity of serious adverse events (SAEs)

+3 more

Secondary study objectives

Complete response (CR) rate

Concentrations of REGN7075 in serum

Disease control rate (DCR)

+36 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups

Experimental Treatment

Group I: Dose Expansion HExperimental Treatment2 Interventions

EGFR-mutant NSCLC Post Third Generation TKI and Post Platinum-Doublet Chemotherapy

Group II: Dose Expansion GExperimental Treatment3 Interventions

Epidermal Growth Factor Receptor (EGFR) -mutant NSCLC Post Third Generation tyrosine kinase inhibitor (TKI)

Group III: Dose Expansion FExperimental Treatment2 Interventions

MSS-CRC with Isolated Lung/Lymph Node Metastases (no active liver and no active peritoneal metastases)

Group IV: Dose Expansion EExperimental Treatment2 Interventions

Microsatellite Stable-Colorectal Cancer (MSS-CRC), with Active Liver Metastases and/or Active Peritoneal Metastases

Group V: Dose Expansion DExperimental Treatment2 Interventions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Group VI: Dose Expansion CExperimental Treatment3 Interventions

Non-Small Cell Lung Cancer (NSCLC)

Group VII: Dose Expansion BExperimental Treatment2 Interventions

Cutaneous Squamous Cell Carcinoma (CSCC)

Group VIII: Dose Expansion AExperimental Treatment2 Interventions

Triple Negative Breast Cancer (TNBC)

Group IX: Dose EscalationExperimental Treatment2 Interventions

Variety of mixed advanced solid tumor types

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

cemiplimab

2016

Completed Phase 2

~910

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for solid tumors include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect healthy cells, leading to side effects. Immunotherapy, such as cemiplimab, enhances the body's immune system to recognize and attack cancer cells. Targeted therapies, like the investigational drug REGN7075, aim to specifically inhibit pathways that are crucial for tumor cell proliferation and survival. These treatments are significant for solid tumor patients as they offer more precise and potentially more effective options for controlling tumor growth and reducing tumor size, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.