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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 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 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (88% lower). The trial reports 4 study locations across 4 states.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05519293
The ClinicalTrials.gov registry entry for NCT05519293 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (88% lower). The listed sponsor is RedCloud Bio, which has 1 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.