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NCT04626635 · ClinicalTrials.gov registry record · 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

A Phase 1 study of Advanced Solid Tumors, sponsored by Regeneron Pharmaceuticals.

Recruiting
Registry status
Phase 1
Development phase
933
Enrollment target
20
Study locations

NCT04626635 is a Phase 1 study of Advanced Solid Tumors that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 933 participants, above the 192-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (386% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT04626635, a Phase 1 study of Advanced Solid Tumors, is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.

RECRUITING
Registry status
Phase 1
Development phase
933 participants
Enrollment target
20
Study locations

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

Advanced Solid Tumors

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

280 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, categorized as Phase 1. The registered enrollment target is 933 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 192-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (386% higher). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.

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.

NCT04626635 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Florida, Ohio.

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.

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).

Who is sponsoring clinical trial NCT04626635?

This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.