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GEN1046 Safety Trial in Patients With Malignant Solid Tumors
NCT03917381 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this trial is to learn about the antibody acasunlimab (an antibody also known as GEN1046) when it is used alone and when it is used together with standard of care treatment (docetaxel) or another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of patients with certain types of cancer. All subjects will receive active drug; no one will receive placebo. This trial has 2 parts. The purpose of the first part is to find out if acasunlimab at various doses is safe and to find out the best doses of acasunlimab to use. The purpose of the second part is to give acasunlimab to more subjects to see how well the doses of acasunlimab selected in the first part work against cancer when given alone and how well they work when given with pembrolizumab with or without chemotherapy. Trial details include: * The average trial duration for an individual subject will be about 74 weeks. * The average treatment duration for an individual subject will be about 21 weeks. * The visit frequency will be weekly at first and lessening over time until visits are only once every 3 weeks.
Conditions Studied
Interventions
- BIOLOGICAL Acasunlimab
- BIOLOGICAL Acasunlimab in combination with docetaxel (in a single expansion cohort)
- BIOLOGICAL Acasunlimab in combination with pembrolizumab (in a separate expansion cohort)
- BIOLOGICAL Acasunlimab in combination with pembrolizumab and standard chemotherapy (in separate expansion cohorts)
Study Locations (20)
Other
- Fakultni nemocnice Brno — Brno
- University Hospital Brno — Brno
- Nemocnice AGEL Ostrava-Vítkovice a.s. — Nový Jičín
- Fakultni nemocnice Olomouc — Olomouc
- High Technology Hospital Medcenter — Batumi
- LLC "TIM - Tbilisi Institute of Medicine" — Tbilisi
Michigan
- University of Michigan — Ann Arbor
- START Midwest — Grand Rapids
North Carolina
- UNC Chapel Hill — Chapel Hill
- Levine Cancer Institute, Atrium Health — Charlotte
Arizona
- Mayo Clinic — Phoenix
Connecticut
- Yale University Cancer Center — New Haven
Florida
- Mayo Clinic — Jacksonville
Georgia
- Emory University — Atlanta
Iowa
- University of Iowa Hospitals — Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 429 participants |
| Start Date | 2019-05-14 |
| Est. Completion | 2026-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03917381
The ClinicalTrials.gov registry entry for NCT03917381 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 429 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 1 condition, with Solid Tumors appearing as the primary indexed condition, and to 4 interventions — of which Acasunlimab 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: NCT03917381 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, Michigan, North Carolina. 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 NCT03917381 about?
NCT03917381 is a clinical study titled "GEN1046 Safety Trial in Patients With Malignant Solid Tumors". The goal of this trial is to learn about the antibody acasunlimab (an antibody also known as GEN1046) when it is used alone and when it is used together with standard of care treatment (docetaxel) or another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of patient...
What is the current status of trial NCT03917381?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 429 participants. The study started on 2019-05-14. Estimated completion is 2026-02.
What conditions does trial NCT03917381 study?
This clinical trial studies the following conditions: 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 NCT03917381?
The interventions under investigation include: Acasunlimab (BIOLOGICAL), Acasunlimab in combination with docetaxel (in a single expansion cohort) (BIOLOGICAL), Acasunlimab in combination with pembrolizumab (in a separate expansion cohort) (BIOLOGICAL), Acasunlimab in combination with pembrolizumab and standard chemotherapy (in separate expansion cohorts) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03917381?
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 NCT03917381 being conducted?
This trial has 20 study locations across Arizona, Connecticut, Florida, Georgia, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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