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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: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by BioEclipse Therapeutics.
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 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (91% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Primary Outcome Measure will be based on the frequency of treatment-emergent Adverse Events and Dose Limiting Toxicities during and after the administration of investigational drug in monotherapy and investigational drug with combination therapy.
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 |
What NCT04282044 shows while recruiting
NCT04282044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (91% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04282044's enrollment target sits among peer trials
60 313th of 454 higher than 135 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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