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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: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Cervical Cancer, sponsored by Precision Biologics.
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 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (81% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate toxicity a safety lead in of 3 to 6 subjects will be conducted. The safety lead in will be 42 days long, consisting of 3 doses of NEO-201 and 1 dose of pembrolizumab followed by a 2 week assessment. All appropriate treatment areas will have access to a the CTCAE version 5.0. A copy of the CTCAE version 5.0 can be downloaded from the CTEP web site http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.
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 |
What NCT03476681 shows while recruiting
NCT03476681 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (81% lower).
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 a single indexed study location in 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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Where NCT03476681's enrollment target sits among peer trials
121 218th of 454 higher than 237 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
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