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NCT05180474 · ClinicalTrials.gov registry record · Phase 1

GEN1047 for Solid Tumors - First in Human (FIH) Trial

A Phase 1 study of Breast Cancer, Breast Neoplasms and Endometrial Cancer, Endometrial Neoplasm, sponsored by Genmab.

Active
Registry status
Phase 1
Development phase
179
Enrollment target
20
Study locations

NCT05180474 is a Phase 1 study of Breast Cancer, Breast Neoplasms and Endometrial Cancer, Endometrial Neoplasm that is active but no longer recruiting, run by Genmab. The registered enrollment target is 179 participants. The trial reports 20 study locations across 7 states.

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The verdict

NCT05180474, a Phase 1 study of Breast Cancer, Breast Neoplasms and Endometrial Cancer, Endometrial Neoplasm, is active but no longer recruiting, sponsored by Genmab.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
179 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this trial is to measure the following in participants with solid tumors who receive GEN1047: * The side effects seen with GEN1047 * What the body does with GEN1047 once it is administered * What GEN1047 does to the body once it is administered * How well GEN1047 works against solid tumors The estimated trial duration for an individual participant is 8 months, consisting of a 28-day screening period, an estimated 3 month treatment period (the duration of treatment may vary for each participant), and an estimated 4 month post-treatment follow-up period (the duration of follow-up may vary for each participant). All participants will receive active drug; no one will be given placebo.

Interventions

  • BIOLOGICAL GEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive tumor cells.

Study Locations (20)

Other

  • Antwerp University Hospital - Edegem
  • Universitair Ziekenhuis Leuven - Leuven
  • Rigshospitalet (Copenhagen University Hospital) - Copenhagen
  • CHU de Besancon - Besançon
  • Institut Bergonié - Bordeaux
  • Centre Léon Bérard - Lyon
  • Institut du Cancer de Montpellier - Montpellier
  • Institut Curie - Paris
  • Hôpital Cochin - Paris
  • CHU Poitiers - Hôpital la Milétrie - Poitiers
  • Institut Claudius Regaud - Toulouse
  • Institut Gustave Roussy - Villejuif
  • IEO Istituto Europeo di Oncologia - Milan
  • Fondazione IRCCS San Gerardo dei Tintori - Monza

California

  • UCLA Department of Medicine Hematology Oncology - Los Angeles

Connecticut

  • Yale University - Yale Cancer Center - New Haven

Michigan

  • Barbara Ann Karmanos Cancer Institute - Detroit

Ohio

  • Case Western Reserve University - Cleveland

Pennsylvania

  • University of Pennsylvania - Philadelphia

Tennessee

  • Sarah Cannon Research Institute - Nashville

Trial Details

FieldValue
Enrollment Target 179 participants
Start Date 2021-12-13
Est. Completion 2026-03-26
Phase Phase 1

Sponsor

Genmab

45 total trials

What the Registry Record Tells You About NCT05180474

The ClinicalTrials.gov registry entry for NCT05180474 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 179 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genmab, which has 45 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Breast Cancer, Breast Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which GEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive tumor cells. is the first listed.

NCT05180474 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, California, Connecticut.

Frequently Asked Questions

What is clinical trial NCT05180474 about?

NCT05180474 is a clinical study titled "GEN1047 for Solid Tumors - First in Human (FIH) Trial". The purpose of this trial is to measure the following in participants with solid tumors who receive GEN1047: * The side effects seen with GEN1047 * What the body does with GEN1047 once it is administered * What GEN1047 does to the body once it is administered * How well GEN1047 works against solid ...

What is the current status of trial NCT05180474?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 179 participants. The study started on 2021-12-13. Estimated completion is 2026-03-26.

What conditions does trial NCT05180474 study?

This clinical trial studies the following conditions: Breast Cancer, Breast Neoplasms, Endometrial Cancer, Endometrial Neoplasm, Ovarian Cancer, Ovarian Neoplasms, Squamous Non Small Cell Lung Cancer (NSCLC-SCC).

What interventions are being tested in trial NCT05180474?

The interventions under investigation include: GEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive tumor cells. (BIOLOGICAL).

Who is sponsoring clinical trial NCT05180474?

This trial is sponsored by Genmab, which has 45 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05180474 being conducted?

This trial has 20 study locations across California, Connecticut, Michigan, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.