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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: Active Phase 1 study of Breast Cancer, Breast Neoplasms and Endometrial Cancer, Endometrial Neoplasm, sponsored by Genmab.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (198% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
DLTs will be graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), v5.0.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 179 participants |
| Start Date | 2021-12-13 |
| Est. Completion | 2026-03-26 |
| Phase | Phase 1 |
What the registry record for NCT05180474 still lists
NCT05180474 is an interventional study that assigns participants to a tested intervention. The registered 179 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (198% higher).
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 names 20 study sites across 7 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05180474's enrollment target sits among peer trials
179 311th of 2000 higher than 1,690 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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