Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03576131 · ClinicalTrials.gov registry record · Phase 1
GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors
A Phase 1 study, sponsored by Genmab.
- Terminated
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT03576131: Clinical Trial Phase 1 study, sponsored by Genmab.
NCT03576131 is a Phase 1 study that was terminated before completion, run by Genmab. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03576131, a Phase 1 study, was terminated before completion, sponsored by Genmab.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of the trial is to evaluate the safety of GEN1029 (HexaBody®-DR5/DR5) in a mixed population of patients with specified solid tumors
Primary Outcome
DLT criteria in the dose escalation phase of this trial are defined as hematologic toxicity including Grade (G) 4 neutropenia/thrombocytopenia for minimal duration of 7 days, G3/4 febrile neutropenia, \>=G3 thrombocytopenia with bleeding, or G4 anemia; and non-hematologic toxicity including G4 infusion-related reactions (IRR) or anaphylaxis, G3 IRR did not resolve to =\<G1 within 24 hours, \>=G3 diarrhea/vomiting (did not respond to optimal treatment within 2 days), G3 nausea (did not respond to
Interventions
- BIOLOGICAL GEN1029 (HexaBody®-DR5/DR5)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2018-04-30 |
| Est. Completion | 2021-10-12 |
| Phase | Phase 1 |
Why NCT03576131 stopped before completion
NCT03576131 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 1 intervention - of which GEN1029 (HexaBody®-DR5/DR5) is the first listed.
NCT03576131 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03576131 about?
NCT03576131 is a clinical study titled "GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors". The purpose of the trial is to evaluate the safety of GEN1029 (HexaBody®-DR5/DR5) in a mixed population of patients with specified solid tumors
What is the current status of trial NCT03576131?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2018-04-30. Estimated completion is 2021-10-12.
What interventions are being tested in trial NCT03576131?
The interventions under investigation include: GEN1029 (HexaBody®-DR5/DR5) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03576131?
This trial is sponsored by Genmab, which has 45 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03576131's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01765777 · 48 participants · NA
Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain
- NCT03073343 · 48 participants · NA
A Prospective, Randomized, Open Label Trial of Two Doses of Oral Betaine
- NCT03431064 · 48 participants
Lung Recruitment Maneuver as a Potential Predictor of Fluid Responsiveness in Mechanically Ventilated Pediatric Patients
- NCT03514602 · 48 participants · NA
Maternal Smoking Cessation and Pediatric Obesity Prevention
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI