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NCT04659629 · ClinicalTrials.gov registry record · Phase 1
NL-201 Monotherapy and in Combination With Pembrolizumab in Patients With Relapsed or Refractory Cancer
A Phase 1 study, sponsored by Neurogene.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
NCT04659629 is a Phase 1 study that has completed, run by Neurogene. The registered enrollment target is 59 participants.
The verdict
NCT04659629, a Phase 1 study, has completed, sponsored by Neurogene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
Study Summary
Parts 1 and 2 The primary purpose of this study is to understand the safety of NL-201 when given intravenously as monotherapy in patients with advanced cancer to evaluate tolerability and to identify a recommended dose and schedule for further testing. In Part 1, there will be backfill cohorts at certain Data Monitoring Committee (DMC)-cleared dose levels and schedules to collect pharmacokinetic (PK), pharmacodynamic (PD) and response data in certain tumor types or to explore additional pre-medication regimens. Parts 3 and 4 The primary purpose of this study is to understand the safety of NL-201 in combination with pembrolizumab when both drugs are given intravenously in patients with advanced cancer, to evaluate tolerability, and to identify a recommended dose and schedule for further testing.
Interventions
- DRUG Pembrolizumab Injection [Keytruda]
- DRUG NL-201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2021-04-26 |
| Est. Completion | 2024-08-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04659629
The ClinicalTrials.gov registry entry for NCT04659629 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neurogene, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab Injection [Keytruda] is the first listed.
NCT04659629 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04659629 about?
NCT04659629 is a clinical study titled "NL-201 Monotherapy and in Combination With Pembrolizumab in Patients With Relapsed or Refractory Cancer". Parts 1 and 2 The primary purpose of this study is to understand the safety of NL-201 when given intravenously as monotherapy in patients with advanced cancer to evaluate tolerability and to identify a recommended dose and schedule for further testing. In Part 1, there will be backfill cohorts at ce...
What is the current status of trial NCT04659629?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2021-04-26. Estimated completion is 2024-08-15.
What interventions are being tested in trial NCT04659629?
The interventions under investigation include: Pembrolizumab Injection [Keytruda] (DRUG), NL-201 (DRUG).
Who is sponsoring clinical trial NCT04659629?
This trial is sponsored by Neurogene, which has 6 total clinical trials registered on ClinicalTrials.gov.
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