GEN1046 Safety Trial in Patients With Malignant Solid Tumors
Public ClinicalTrials.gov record NCT03917381. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03917381
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 429 participants
Conditions and interventions
Conditions
Interventions
- 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
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 13, 2019
- Primary completion
- Mar 31, 2025
- Completion
- Aug 30, 2026
- Last update posted
- Aug 3, 2026
2019 – 2026
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | — |
| Yale University Cancer Center | New Haven | Connecticut | 06520-8028 | — |
| Mayo Clinic | Jacksonville | Florida | 32224 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| University of Iowa Hospitals | Iowa City | Iowa | 52242 | — |
| Norton Healthcare Inc | Louisville | Kentucky | 40202 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| START Midwest | Grand Rapids | Michigan | 49546 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| NYU Langone | New York | New York | 10016 | — |
| UNC Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
| Levine Cancer Institute, Atrium Health | Charlotte | North Carolina | 28204 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 43 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03917381, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 3, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03917381 live on ClinicalTrials.gov.