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RECRUITING Phase 1

A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers

NCT04626635 · View on ClinicalTrials.gov ↗

Study 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)

Conditions Studied

Interventions

  • DRUG Bevacizumab
  • DRUG Cemiplimab
  • DRUG REGN7075
  • DRUG Trifluridine-tipiracil
  • DRUG Platinum-based doublet chemotherapy

Study Locations (20)

California

  • Valkyrie Clinical Trials — Los Angeles
  • University of California Los Angeles (UCLA) Medical Center — Los Angeles
  • The Regents of the University of California, San Francisco — San Francisco

Florida

  • University of Florida Health — Gainesville
  • Moffitt Cancer Center — Tampa

Ohio

  • University of Cincinnati Medical Center — Cincinnati
  • The Stefanie Spielman Comprehensive Breast Center — Columbus

Texas

  • MD Anderson Cancer Center — Houston
  • South Texas Oncology And Hematology — San Antonio

Colorado

  • University of Colorado Hospital - Anschutz Cancer Pavilion - Lung Cancer Clinic — Aurora

Illinois

  • University of Illinois Cancer Center — Chicago

Iowa

  • University of Iowa Hospitals and Clinics — Iowa City

Massachusetts

  • Dana Farber Cancer Institute Brookline Avenue — Boston

Trial Details

FieldValue
Enrollment Target 933 participants
Start Date 2020-12-21
Est. Completion 2027-04-07
Phase Phase 1

Sponsor

Regeneron Pharmaceuticals

290 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04626635

The ClinicalTrials.gov registry entry for NCT04626635 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 933 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 5 interventions — of which Bevacizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04626635 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Florida, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04626635 about?

NCT04626635 is a clinical study titled "A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers". 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 m...

What is the current status of trial NCT04626635?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 933 participants. The study started on 2020-12-21. Estimated completion is 2027-04-07.

What conditions does trial NCT04626635 study?

This clinical trial studies the following conditions: Advanced Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04626635?

The interventions under investigation include: Bevacizumab (DRUG), Cemiplimab (DRUG), REGN7075 (DRUG), Trifluridine-tipiracil (DRUG), Platinum-based doublet chemotherapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04626635?

This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04626635 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial