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GEN1047 for Solid Tumors - First in Human (FIH) Trial
NCT05180474 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05180474
The ClinicalTrials.gov registry entry for NCT05180474 describes a study currently listed as active not 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 179 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genmab, which has 59 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT05180474 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, California, Connecticut. 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 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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05180474?
This trial is sponsored by Genmab, which has 59 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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