ClinicalTrials.gov record
Active, not recruiting Phase 1Phase 2 Interventional

GEN1046 Safety Trial in Patients With Malignant Solid Tumors

ClinicalTrials.gov ID: NCT03917381

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.

ClinicalTrials.gov public records Last synced May 6, 2026, 8:25 AM EDT

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

Study identification

NCT ID
NCT03917381
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Genmab
Industry
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
Apr 5, 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 Apr 5, 2026 · Synced May 6, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03917381 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →