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NCT03917381 · ClinicalTrials.gov registry record · Phase 1
GEN1046 Safety Trial in Patients With Malignant Solid Tumors
A Phase 1 study of Solid Tumors, sponsored by Genmab.
- Active
- Registry status
- Phase 1
- Development phase
- 429
- Enrollment target
- 20
- Study locations
NCT03917381: Active Phase 1 study of Solid Tumors, sponsored by Genmab.
NCT03917381 is a Phase 1 study of Solid Tumors that is active but no longer recruiting, run by Genmab. The registered enrollment target is 429 participants, above the 281-participant average among 125 other Solid Tumors trials with a reported enrollment target (53% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03917381, a Phase 1 study of Solid Tumors, is active but no longer recruiting, sponsored by Genmab.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 429 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
In this trial, a DLT was defined as any grade 5 toxicity, grade 4 neutropenia lasting more than 7 days, grade 3 and 4 febrile neutropenia, grade 4 thrombocytopenia for minimal duration of 7 days, grade 3\&4 hemorrhage associated with thrombocytopenia of ≥ grade 3 requiring platelet transfusion, grade 4 anemia, liver toxicity (transaminases and bilirubin elevations), grade 3 nausea that didn't respond to optimal antiemetic treatment within 7 days, grade ≥3 vomiting that didn't respond to optimal
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 |
What the registry record for NCT03917381 still lists
NCT03917381 is an interventional study that assigns participants to a tested intervention. The registered 429 participants enrollment target is mid-sized for trials with a published cap, above the 281-participant average among 125 other Solid Tumors trials with a reported enrollment target (53% higher).
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.
NCT03917381 names 20 study sites across 13 states, led by Other, Michigan, North Carolina.
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.
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).
Who is sponsoring clinical trial NCT03917381?
This trial is sponsored by Genmab, which has 45 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03917381's enrollment target sits among peer trials
429 11th of 125 higher than 115 of 125 other Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumors 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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