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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 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.

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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.

Conditions Studied

Solid Tumors

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

FieldValue
Enrollment Target 429 participants
Start Date 2019-05-14
Est. Completion 2026-02
Phase Phase 1

Sponsor

Genmab

45 total trials

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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, categorized as Phase 1. The registered enrollment target is 429 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 281-participant average among 125 other Solid Tumors trials with a reported enrollment target (53% higher). The listed sponsor is Genmab, which has 45 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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