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NCT04205227 · ClinicalTrials.gov registry record · Phase 1
ENB003 Plus Pembrolizumab Phase 1b/2a in Solid Tumors
A Phase 1 study of Cancer and Pancreatic Cancer, sponsored by ENB Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 137
- Enrollment target
- 5
- Study locations
NCT04205227: Active Phase 1 study of Cancer and Pancreatic Cancer, sponsored by ENB Therapeutics.
NCT04205227 is a Phase 1 study of Cancer and Pancreatic Cancer that is active but no longer recruiting, run by ENB Therapeutics. The registered enrollment target is 137 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04205227, a Phase 1 study of Cancer and Pancreatic Cancer, is active but no longer recruiting, sponsored by ENB Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 137 participants
- Enrollment target
- 5
- Study locations
Study Summary
First-in Human study evaluating the safety, tolerability and efficacy of ENB003 in combination with Pembrolizumab in solid tumors. The study is separated into two parts. Part A is a 3+3 dose escalation to define the recommended RP2D; this part will include metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer patients subjects, but other solid tumors will be allowed. Once the RP2D is selected, the study will be expanded into metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer subjects. A small number of sarcoma subjects will be included, as exploratory.
Primary Outcome
Based on observed or reported AEs. AEs will be evaluated and classified according to NCI CTCAE Version 5.0
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG ENB003
Study Locations (5)
New South Wales
- Border Medical Oncology - Albury
- Blacktown Oncology - Blacktown
- Kinghorn-St Vincent's Hospital - Darlinghurst
California
- Cedars Sinai-The Angeles Clinic - Los Angeles
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2020-02-18 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 1 |
What the registry record for NCT04205227 still lists
NCT04205227 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (96% lower).
The record links to 5 conditions, with Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04205227 lists 5 locations in 3 states (New South Wales, California, Texas).
Frequently Asked Questions
What is clinical trial NCT04205227 about?
NCT04205227 is a clinical study titled "ENB003 Plus Pembrolizumab Phase 1b/2a in Solid Tumors". First-in Human study evaluating the safety, tolerability and efficacy of ENB003 in combination with Pembrolizumab in solid tumors. The study is separated into two parts. Part A is a 3+3 dose escalation to define the recommended RP2D; this part will include metastatic melanoma, platinum resistant ova...
What is the current status of trial NCT04205227?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 137 participants. The study started on 2020-02-18. Estimated completion is 2026-03-31.
What conditions does trial NCT04205227 study?
This clinical trial studies the following conditions: Cancer, Pancreatic Cancer, Melanoma, Solid Tumor, Ovary Cancer.
What interventions are being tested in trial NCT04205227?
The interventions under investigation include: Pembrolizumab (DRUG), ENB003 (DRUG).
Who is sponsoring clinical trial NCT04205227?
This trial is sponsored by ENB Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04205227 being conducted?
This trial has 5 study locations across California, Texas, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04205227's enrollment target sits among peer trials
137 275th of 615 higher than 341 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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