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NCT05519293 · ClinicalTrials.gov registry record · Phase 1
Phase I/IIa Study of H002 in NSCLC With Active EGFR Mutation
A Phase 1 study of Non-Small Cell Lung Cancer, sponsored by RedCloud Bio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 76
- Enrollment target
- 4
- Study locations
NCT05519293: Recruiting Phase 1 study of Non-Small Cell Lung Cancer, sponsored by RedCloud Bio.
NCT05519293 is a Phase 1 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by RedCloud Bio. The registered enrollment target is 76 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (88% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05519293, a Phase 1 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by RedCloud Bio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 76 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a phase I/IIa, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of H002 when given orally in patients with active EGFR mutation locally advanced or metastatic non-small cell lung cancer (NSCLC). The study will contain two parts: Part A is dose escalation phase (i.e., Phase I) and Part B is dose expansion phase (i.e., Phase IIa).
Conditions Studied
Interventions
- DRUG H002
Study Locations (4)
California
- Valkyrie Clinical Trials - Los Angeles
Massachusetts
- Dana-Farber Cancer Institute - Boston
New York
- Columbia University - New York
Virginia
- NEXT Virginia - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2022-12-15 |
| Est. Completion | 2025-02-28 |
| Phase | Phase 1 |
What NCT05519293 shows while recruiting
NCT05519293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which H002 is the first listed.
NCT05519293 reports a single indexed study location in California, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT05519293 about?
NCT05519293 is a clinical study titled "Phase I/IIa Study of H002 in NSCLC With Active EGFR Mutation". This is a phase I/IIa, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of H002 when given orally in patients with active EGFR mutation locally advanced or metastatic non-small cell lung cancer (NSCLC). The study will conta...
What is the current status of trial NCT05519293?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2022-12-15. Estimated completion is 2025-02-28.
What conditions does trial NCT05519293 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT05519293?
The interventions under investigation include: H002 (DRUG).
Who is sponsoring clinical trial NCT05519293?
This trial is sponsored by RedCloud Bio, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05519293 being conducted?
This trial has 4 study locations across California, Massachusetts, New York, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-Small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05519293's enrollment target sits among peer trials
76 274th of 454 higher than 177 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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.
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