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Investigating the safety and effectiveness of REGN7075 with cemiplimab for advanced cancers

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

Phase1; Phase2 Interventional Regeneron Pharmaceuticals · NCT04626635

This study is testing a new drug called REGN7075, alone and with another drug called cemiplimab, to see if it can safely help adults with advanced solid tumors.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment933 (estimated)
Ages18 Years and up
SexAll
SponsorRegeneron Pharmaceuticals Industry-sponsored
Drugs / interventionsimmunotherapy, radiation, prednisone, cemiplimab, chemotherapy
Locations57 sites (Los Angeles, California and 56 other locations)
Trial IDNCT04626635 on ClinicalTrials.gov

What this trial studies

This clinical trial is evaluating the investigational drug REGN7075, both alone and in combination with cemiplimab, for adult patients with advanced solid tumors. The study aims to determine the safety, tolerability, and optimal dosing of REGN7075, as well as its effectiveness in treating these cancers. Participants will receive REGN7075 with or without chemotherapy, and the trial will monitor side effects and how the drug works in the body. The study includes various advanced solid tumor types and is designed to gather critical data on this new treatment approach.

Who should consider this trial

Good fit: Ideal candidates are adults with advanced solid tumors who have not previously been treated with PD-1/PD-L1 inhibitors.

Not a fit: Patients currently participating in another therapeutic study or those who have received prior PD-1/PD-L1 targeted therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors.

How similar studies have performed: Other studies have shown promise with similar combinations of immunotherapy and targeted treatments, but this specific combination is novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Los Angeles, California and 56 other locations

+7 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid TumorsVariety of mixed advanced solid tumor typesFirst in Human
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.