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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 is a Phase 1 study that was terminated before completion, run by Genmab. The registered enrollment target is 31 participants.
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").
Interventions
- BIOLOGICAL GEN1053
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2022-10-04 |
| Est. Completion | 2024-05-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05435339
The ClinicalTrials.gov registry entry for NCT05435339 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genmab, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GEN1053 is the first listed.
NCT05435339 reports 0 study locations.
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.
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