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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: Completed Phase 1 study, sponsored by Neurogene.
NCT04659629 is a Phase 1 study that has completed, run by Neurogene. The registered enrollment target is 59 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Evaluation of tolerability of NL-201 as measured by number of subjects with dose limiting toxicities (DLTs)
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 |
What the finished NCT04659629 record still lists
NCT04659629 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab Injection [Keytruda] is the first listed.
NCT04659629 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04659629's enrollment target sits among peer trials
59 895th of 2000 higher than 1,106 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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