A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Plain English Summary

A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers is a Phase 2 clinical trial sponsored by Regeneron Pharmaceuticals studying Advanced Solid Tumors. This trial is testing a new drug, REGN7075, alone and with another drug, cemiplimab, to see how safe and effective they are for advanced cancers. It is for adults with advanced solid tumors who have not responded to or cannot tolerate standard treatments. Participants will receive REGN7075 by itself or in combination with cemiplimab, potentially with chemotherapy, and will have regular check-ups and tests. Alternative treatments may include chemotherapy, targeted therapy, or immunotherapy, depending on the specific cancer type and previous treatments. The trial aims to enroll 933 participants.

Official Summary

This study is researching an investigational drug called marlotamig (REGN7075) by itself and in combination with cemiplimab with or without chemotherapy. 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 and tolerable marlotamig is by itself and in combination with cemiplimab (with or without chemotherapy), and to find out what is the best dose of marlotamig to be given to patients with advanced solid tumors when combined with cemiplimab (with or without chemotherapy). Another aim of the study is to see how effective marlotamig by itself, or in combination with cemiplimab (with or without chemotherapy), is at treating cancer patients. The study is also looking at: * Side effects that may be experienced by people taking marlotamig by itself and in combination with cemiplimab with or without chemotherapy * How marlotamig works in the body by itself and in combination with cemiplimab with or without chemotherapy * How much marlotamig is present in the blood when given by itself and in combination with cemiplimab with or without chemotherapy * To see if marlotamig by itself and in combination with cemiplimab with or without chemotherapy works to treat cancer by controlling the proliferation of tumor cells to shrink the tumor * Whether the body makes antibodies against the study drugs (marlotamig and cemiplimab) (which could make the drug less effective or could lead to side effects)

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with advanced solid tumors that have spread or cannot be removed by surgery. Patients who have not previously been treated with drugs targeting PD-1 or PD-L1 (for certain groups). Individuals with good general health and organ function, and a life expectancy of at least 3 months. People with active brain tumors, certain autoimmune diseases, or those requiring high-dose steroids may not be eligible. This trial is studying Advanced Solid Tumors, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how safe the study drugs are by tracking side effects and determining the best dose, which is crucial for patient well-being and treatment effectiveness. The specific primary outcome measures are: The incidence of Dose-Limiting Toxicities (DLTs) during the DLT period (Up to 6 weeks); Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) (Approximately 90 days from last dose; up to 5 years); Incidence and severity of Adverse Events of Special Interest (AESIs) (Approximately 90 days from last dose; up to 5 years); Incidence and severity of Serious Adverse Events (SAEs) (Approximately 90 days from last dose; up to 5 years); Incidence and severity of grade ≥3 laboratory abnormalities (Approximately 90 days from last dose; up to 5 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses the need for new treatments for advanced solid tumors by investigating a novel combination therapy that aims to boost the immune system's attack on cancer cells. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Advanced Solid Tumors, where improved treatment options are needed.

Investor Insight

This trial signals Regeneron's continued investment in oncology, targeting a broad range of advanced solid tumors with a novel bispecific antibody, potentially offering a new option in a competitive i Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval. The large enrollment target of 933 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the specific type of cancer being studied, the potential benefits and risks of REGN7075 and cemiplimab, and how this trial compares to standard treatments. Participation involves regular clinic visits for drug administration, blood tests, scans to monitor tumor response, and reporting any side effects. You will need to provide a tumor tissue sample from a new biopsy, and your general health and organ function will be closely monitored. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SEQUENTIAL
• Masking: NONE
• Enrollment: 933 participants

Interventions

• DRUG: REGN7075 — Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)
• DRUG: Cemiplimab — Administered concomitantly Q3W by IV infusion or SC injection
• DRUG: Platinum-based doublet chemotherapy — Administered IV Q3W
• DRUG: Bevacizumab — Administered per protocol
• DRUG: Trifluridine-tipiracil — Administered per protocol

Primary Outcomes

• The incidence of Dose-Limiting Toxicities (DLTs) during the DLT period (Up to 6 weeks)
• Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) (Approximately 90 days from last dose; up to 5 years)
• Incidence and severity of Adverse Events of Special Interest (AESIs) (Approximately 90 days from last dose; up to 5 years)
• Incidence and severity of Serious Adverse Events (SAEs) (Approximately 90 days from last dose; up to 5 years)
• Incidence and severity of grade ≥3 laboratory abnormalities (Approximately 90 days from last dose; up to 5 years)

Secondary Outcomes

• Concentrations of marlotamig in serum (Up to 5 years)
• ORR (Up to 5 years)
• Progression Free Survival (PFS) (Up to 5 years)
• Duration of Response (DOR) (Up to 5 years)
• Disease Control Rate (DCR) (Up to 5 years)

Full Eligibility Criteria

Key Inclusion Criteria:

1. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
2. Has histologically or cytologically confirmed cancer that meets criteria as defined in the protocol
3. Expansion Cohorts only: Is anti-Programmed cell Death protein-1 (PD-1)/Programmed cell Death Ligand-1 (PD-L1) naïve, defined as never having previously been treated with a drug that targets the PD-1
4. Has at least 1 lesion that meets study criteria as defined in the protocol
5. Willing to provide tumor tissue from newly obtained biopsy (at a minimum core biopsy) from a tumor site that has not been previously irradiated
6. Has adequate organ and bone marrow function as defined in the protocol
7. In the judgement of the investigator, has a life expectancy of at least 3 months

Key Exclusion Criteria:

1. Is currently participating in another study of a therapeutic agent
2. Has participated in any study of an investigational agent or an investigational device within 4 weeks of the first administration of study drug as defined in the protocol
3. Has received treatment with an approved systemic therapy within 4 weeks of the first administration of study drug or has not yet recovered (ie, grade 1 or baseline) from any acute toxicities
4. Has received recent anti-Epidermal Growth Factor Receptor (EGFR) antibody therapy as defined in the protocol
5. Has received radiation therapy or major surgery within 14 days of the first administration of study drug or has not recovered (ie, grade 1 or baseline) from adverse events
6. Has received any previous systemic, non-immunomodulatory biologic therapy within 4 weeks of first administration of study drug.
7. Has had prior anti-cancer immunotherapy within 5 half-lives prior to study drug as defined in the protocol
8. Has second malignancy that is progressing or requires active treatment as defined in the protocol
9. Has any condition requiring ongoing/continuous corticosteroid therapy (\>10 mg prednisone/day or anti-inflammatory equivalent) within 1-2 weeks prior to the first dose of study drug as defined in the protocol
10. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments as defined in the protocol
11. Has untreated or active primary brain tumor, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression
12. Has encephalitis, meningitis, organic brain disease (eg, Parkinson's disease) or uncontrolled seizures within 1 year prior to the first dose of study drug
13. Has any ongoing inflammatory skin disease as defined in the protocol

NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply

Trial Locations

• Valkyrie Clinical Trials, Los Angeles, California, United States
• University of California Los Angeles (UCLA) Medical Center, Los Angeles, California, United States
• The Regents of the University of California, San Francisco, San Francisco, California, United States
• University of Colorado Hospital - Anschutz Cancer Pavilion - Lung Cancer Clinic, Aurora, Colorado, United States
• University of Florida Health, Gainesville, Florida, United States
• Moffitt Cancer Center, Tampa, Florida, United States
• University of Illinois Cancer Center, Chicago, Illinois, United States
• University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
• Dana Farber Cancer Institute Brookline Avenue, Boston, Massachusetts, United States
• START Midwest - Cancer & Hematology Centers of Western Michigan, PC, Grand Rapids, Michigan, United States
• ...and 10 more locations

Frequently Asked Questions

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