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NCT03476681 · ClinicalTrials.gov registry record · Phase 1
Study of NEO-201 in Solid Tumors Expansion Cohorts
A Phase 1 study of Non-Small Cell Lung Cancer and Cervical Cancer, sponsored by Precision Biologics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 121
- Enrollment target
- 2
- Study locations
NCT03476681 is a Phase 1 study of Non-Small Cell Lung Cancer and Cervical Cancer that is actively recruiting participants, run by Precision Biologics. The registered enrollment target is 121 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT03476681, a Phase 1 study of Non-Small Cell Lung Cancer and Cervical Cancer, is actively recruiting participants, sponsored by Precision Biologics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 121 participants
- Enrollment target
- 2
- Study locations
Study Summary
The open label, first-in-human, phase 1, dose escalation component in refractory solid tumors has been completed. The Maximum Tolerated Dose and Recommended Phase 2 Dose (RP2D) was determined to be 1.5mg/kg. The Expansion Phase of this study is currently enrolling subjects with non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), cervical and uterine cancers who progressed on front line therapy. Subjects will be treated with NEO-201 at the RP2D (1.5 mg/kg) every 2 weeks in combination with pembrolizumab, given 1 day after the NEO-201, at 400 mg IV every 6 weeks.
Conditions Studied
Interventions
- DRUG NEO-201 in combination with pembrolizumab
Study Locations (2)
Maryland
- National Cancer Institute - Bethesda
Virginia
- INOVA Schar Cancer Institute - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2019-01-18 |
| Est. Completion | 2029-01-15 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03476681
The ClinicalTrials.gov registry entry for NCT03476681 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 121 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 (82% lower). The listed sponsor is Precision Biologics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which NEO-201 in combination with pembrolizumab is the first listed.
NCT03476681 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Maryland, Virginia.
Frequently Asked Questions
What is clinical trial NCT03476681 about?
NCT03476681 is a clinical study titled "Study of NEO-201 in Solid Tumors Expansion Cohorts". The open label, first-in-human, phase 1, dose escalation component in refractory solid tumors has been completed. The Maximum Tolerated Dose and Recommended Phase 2 Dose (RP2D) was determined to be 1.5mg/kg. The Expansion Phase of this study is currently enrolling subjects with non small cell lung ...
What is the current status of trial NCT03476681?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 121 participants. The study started on 2019-01-18. Estimated completion is 2029-01-15.
What conditions does trial NCT03476681 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Cervical Cancer, Head and Neck Squamous Cell Carcinoma, Uterine Cancer.
What interventions are being tested in trial NCT03476681?
The interventions under investigation include: NEO-201 in combination with pembrolizumab (DRUG).
Who is sponsoring clinical trial NCT03476681?
This trial is sponsored by Precision Biologics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03476681 being conducted?
This trial has 2 study locations across Maryland, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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