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NCT04332653 · ClinicalTrials.gov registry record · Phase 1
NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
A Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, sponsored by NeoImmuneTech.
- Completed
- Registry status
- Phase 1
- Development phase
- 215
- Enrollment target
- 8
- Study locations
NCT04332653: Completed Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, sponsored by NeoImmuneTech.
NCT04332653 is a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer that has completed, run by NeoImmuneTech. The registered enrollment target is 215 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (67% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04332653, a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, has completed, sponsored by NeoImmuneTech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 215 participants
- Enrollment target
- 8
- Study locations
Study Summary
The main purposes of Phase 1b of this study are to determine the following in participants with advanced solid tumors: * Safety and tolerability of NT-I7 in combination with pembrolizumab * Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) The main purpose of Phase 2a of this study is to assess the preliminary anti-tumor activity of NT-I7 in combination with pembrolizumab in participants with checkpoint inhibitor (CPI) treated and naïve relapsed and refractory (R/R) tumors. The main purpose of the Biomarker Cohort is to assess a potential correlation between tumor infiltrating lymphocytes (TILs) and clinical benefits in participants with CPI-naïve R/R ovarian cancer (OC).
Primary Outcome
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. A SAE was defined as any AE that resulted in any of the following outcomes: 1. Death; 2. A life-threatening AE; 3. An AE that resulted in inpatient hospitalization or prolongation of existing hospitalization
Conditions Studied
Interventions
- DRUG NT-I7
- DRUG pembrolizumab (KEYTRUDA®)
Study Locations (8)
Texas
- Mary Crowley Cancer Research - Dallas
- MD Anderson Cancer Center - Houston
Florida
- Moffit Cancer Center - Tampa
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit
Missouri
- Washington University School of Medicine in St. Louis - St Louis
North Carolina
- Duke University Medical Center - Durham
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Tennessee
- Sarah Cannon Research Institute - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2020-06-10 |
| Est. Completion | 2025-01-13 |
| Phase | Phase 1 |
What the finished NCT04332653 record still lists
NCT04332653 is an interventional study that assigns participants to a tested intervention. The registered 215 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 (67% lower).
The record links to 7 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which NT-I7 is the first listed.
NCT04332653 lists 8 locations in 7 states (Texas, Florida, Michigan).
Frequently Asked Questions
What is clinical trial NCT04332653 about?
NCT04332653 is a clinical study titled "NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors". The main purposes of Phase 1b of this study are to determine the following in participants with advanced solid tumors: * Safety and tolerability of NT-I7 in combination with pembrolizumab * Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) The main purpose of Phase 2a of this...
What is the current status of trial NCT04332653?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 215 participants. The study started on 2020-06-10. Estimated completion is 2025-01-13.
What conditions does trial NCT04332653 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Triple Negative Breast Cancer, Small-cell Lung Cancer.
What interventions are being tested in trial NCT04332653?
The interventions under investigation include: NT-I7 (DRUG), pembrolizumab (KEYTRUDA®) (DRUG).
Who is sponsoring clinical trial NCT04332653?
This trial is sponsored by NeoImmuneTech, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04332653 being conducted?
This trial has 8 study locations across Florida, Michigan, Missouri, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04332653's enrollment target sits among peer trials
215 159th of 454 higher than 296 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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