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NCT04282044 · ClinicalTrials.gov registry record · Phase 1
Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
A Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by BioEclipse Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 3
- Study locations
NCT04282044 is a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer that is actively recruiting participants, run by BioEclipse Therapeutics. The registered enrollment target is 60 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (91% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT04282044, a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, is actively recruiting participants, sponsored by BioEclipse Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 3
- Study locations
Study Summary
This clinical study is an open-label, Phase 1, dose-escalation study to determine the safety, tolerability, and efficacy of the drug product produced by Administering CRX100 alone and in combination with Pembrolizumab in advanced solid malignancies. Patients will be screened and evaluated to determine whether or not they meet stated inclusion criteria. Enrolled subjects will undergo leukapheresis to enable the ex vivo generation of CRX100. Patients with non-small cell lung cancer (NSCLC), ovarian cancer, colorectal cancer, hepatocellular carcinoma (HCC), malignant melanoma (excluding uveal melanoma), gastric cancer, triple negative breast cancer, and osteosarcoma. The study will start with monotherapy dose escalation followed by combination cohorts.
Conditions Studied
Interventions
- BIOLOGICAL CRX100 suspension for infusion
- COMBINATION_PRODUCT Fludarabine
- COMBINATION_PRODUCT Cyclophosphamide
Study Locations (3)
California
- UC San Diego Moores Cancer Center - La Jolla
- Stanford University - Stanford
Arizona
- HonorHealth Research Institute - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-01-08 |
| Est. Completion | 2026-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04282044
The ClinicalTrials.gov registry entry for NCT04282044 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 60 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 (91% lower). The listed sponsor is BioEclipse Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which CRX100 suspension for infusion is the first listed.
NCT04282044 reports 3 study locations spanning 2 distinct geographic areas - top geographies include California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04282044 about?
NCT04282044 is a clinical study titled "Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies". This clinical study is an open-label, Phase 1, dose-escalation study to determine the safety, tolerability, and efficacy of the drug product produced by Administering CRX100 alone and in combination with Pembrolizumab in advanced solid malignancies. Patients will be screened and evaluated to determi...
What is the current status of trial NCT04282044?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2021-01-08. Estimated completion is 2026-10.
What conditions does trial NCT04282044 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Colorectal Cancer, Gastric Cancer, Hepatocellular Carcinoma, Triple Negative Breast Cancer.
What interventions are being tested in trial NCT04282044?
The interventions under investigation include: CRX100 suspension for infusion (BIOLOGICAL), Fludarabine (COMBINATION_PRODUCT), Cyclophosphamide (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04282044?
This trial is sponsored by BioEclipse Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04282044 being conducted?
This trial has 3 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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