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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

COMBINE-EGFR-1 Trial Summary

This trial is testing the safety and efficacy of REGN7075, a monotherapy or in combination with cemiplimab, for patients with advanced solid tumors. The primary objective is to assess the safety and tolerability of the REGN7075 lead-in and REGN7075/cemiplimab combination. The secondary objective is to assess the preliminary efficacy of the REGN7075/cemiplimab combination within selected advanced solid tumor-specific cohorts.

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.Check my eligibility
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.See study design
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.

COMBINE-EGFR-1 Trial 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.

COMBINE-EGFR-1 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Complete response (CR) rate
Concentrations of REGN7075 in serum
Disease control rate (DCR)
+36 more

COMBINE-EGFR-1 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
~570

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
617 Previous Clinical Trials
379,436 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
260 Previous Clinical Trials
250,273 Total Patients Enrolled

Media Library

Cemiplimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04626635 — Phase 1 & 2
Solid Tumors Research Study Groups: Dose Expansion G, Dose Expansion F, Dose Expansion H, Dose Expansion A, Dose Expansion B, Dose Expansion C, Dose Expansion D, Dose Expansion E, Dose Escalation
Solid Tumors Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT04626635 — Phase 1 & 2
Cemiplimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04626635 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there a plethora of Canadian locations offering this clinical trial?

"The clinical trial is enrolling patients at START Midwest - Cancer & Hematology Centers of Western Michigan, PC in Nashville, Tennessee, Tennessee Oncology Sarah Cannon Research Institute in Grand Rapids, Michigan and The Regents of the University of California, San Francisco (UCSF)in New york City as well as 14 additional sites."

Answered by AI

To what applications is REGN7075 typically applied?

"REGN7075 is most often prescribed to combat alk gene mutation, but has also been found effective in treating malignancy, advanced directives and metastatic cutaneous squamous cell carcinoma."

Answered by AI

How many individuals are the maximum allowable participants for this research endeavor?

"Regeneron Pharmaceuticals require 402 eligible participants to successfully complete the trial hosted in START Midwest - Cancer & Hematology Centers of Western Michigan, PC (Nashville, Tennessee) and Tennessee Oncology Sarah Cannon Research Institute (Grand Rapids, Michigan)."

Answered by AI

What effect is this investigation expected to have?

"This clinical trial, to be monitored up to five years from the last dose administered, aims to evaluate the incidence of dose-limiting toxicities (DLTs) during an initial 90 day period. Secondary outcomes include patient reported symptom levels and functioning as measured by EORTC QLQ-BR23 and EORTC QLQ-C30; both are self report questionnaires rated on four point Likert scales with changes in score ranging from small (5 - 10 points) to moderate (10 - 20 points)."

Answered by AI

Are there any available slots in this research endeavor?

"Correct. According to clinicaltrials.gov, this research endeavor, which was initially posted on December 21st 2020 is actively looking for participants. From 14 different medical sites, the trial aims to recruit a total of 402 patients."

Answered by AI

Has REGN7075 been subject to any further research?

"Currently, 56 studies are in progress with REGN7075. 4 of these trials have reached the advanced stage 3. Although Barcelona and California host most of them, 1738 other locations carry out clinical research on this drug too."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers
2020. "A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04626635.
~310 spots leftby Aug 2026
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