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NCT05435339 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy
A Phase 1 study, sponsored by Genmab.
- Terminated
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT05435339: Clinical Trial Phase 1 study, sponsored by Genmab.
NCT05435339 is a Phase 1 study that was terminated before completion, run by Genmab. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05435339, a Phase 1 study, was terminated before completion, sponsored by Genmab.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
The drug that will be investigated in the study is GEN1053. GEN1053 is an antibody designed to (re)activate and increase antitumor immunity. Since this is the first study of GEN1053 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN1053 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN1053. GEN1053 will be studied in a broad group of cancer patients, having different kinds of solid tumors. All participants will get GEN1053. The study consists of two parts: Part 1 tests increasing doses of GEN1053 ("escalation"), followed by Part 2 which tests the recommended phase 2 dose GEN1053 dose from Part 1 ("expansion").
Primary Outcome
The occurrence of any of the following toxicities, assessed as related to trial treatment, were considered DLTs: All Grade 5 events, Grade 4 anaphylaxis, infusion-related reactions and neutropenia for ≥7 days, Grade 3/4 febrile neutropenia, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with clinically significant bleeding, Grade 4 anemia, Grade 4 aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin elevation/Grade 3 that did not recover to ≤Grade 1 within 14 days,
Interventions
- BIOLOGICAL GEN1053
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2022-10-04 |
| Est. Completion | 2024-05-24 |
| Phase | Phase 1 |
Why NCT05435339 stopped before completion
NCT05435339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which GEN1053 is the first listed.
NCT05435339 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05435339 about?
NCT05435339 is a clinical study titled "A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy". The drug that will be investigated in the study is GEN1053. GEN1053 is an antibody designed to (re)activate and increase antitumor immunity. Since this is the first study of GEN1053 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN1053 d...
What is the current status of trial NCT05435339?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2022-10-04. Estimated completion is 2024-05-24.
What interventions are being tested in trial NCT05435339?
The interventions under investigation include: GEN1053 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05435339?
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 NCT05435339's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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
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