Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies

NCT04282044 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 60 participants
Start Date 2021-01-08
Est. Completion 2026-10
Phase Phase 1

Sponsor

BioEclipse Therapeutics

28 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioEclipse Therapeutics, which has 28 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 9 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions — of which CRX100 suspension for infusion is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04282044 reports 3 study locations spanning 2 distinct geographic areas — top geographies include California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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: Colorectal Cancer, Gastric Cancer, Non-small Cell Lung Cancer, Hepatocellular Carcinoma, Triple Negative Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04282044?

The interventions under investigation include: CRX100 suspension for infusion (BIOLOGICAL), Fludarabine (COMBINATION_PRODUCT), Cyclophosphamide (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04282044?

This trial is sponsored by BioEclipse Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial