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COMPLETED Phase 1

GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy

NCT04601402 · View on ClinicalTrials.gov ↗

Study Summary

This is a phase I/Ib, first-in-human (FIH), open-label, dose escalation and dose expansion study to evaluate the safety and tolerability, biological and clinical activities of GEN-001 in patients with locally advanced or metastatic solid tumors who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination), when administered as combined with avelumab.

Interventions

  • DRUG Avelumab
  • DRUG GEN-001

Study Locations (3)

Connecticut

  • Yale Cancer Center — New Haven

Georgia

  • Emory University Winship Cancer Institute — Atlanta

Oregon

  • Oregon Health & Science University — Portland

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2020-10-26
Est. Completion 2023-01-11
Phase Phase 1

Sponsor

Genome & Company

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04601402

The ClinicalTrials.gov registry entry for NCT04601402 describes a study currently listed as completed. 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 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genome & Company, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Solid Tumor appearing as the primary indexed condition, and to 2 interventions — of which Avelumab 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: NCT04601402 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Connecticut, Georgia, Oregon. 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 NCT04601402 about?

NCT04601402 is a clinical study titled "GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy". This is a phase I/Ib, first-in-human (FIH), open-label, dose escalation and dose expansion study to evaluate the safety and tolerability, biological and clinical activities of GEN-001 in patients with locally advanced or metastatic solid tumors who have progressed on at least two lines of approved t...

What is the current status of trial NCT04601402?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2020-10-26. Estimated completion is 2023-01-11.

What conditions does trial NCT04601402 study?

This clinical trial studies the following conditions: Solid Tumor, Non Small Cell Lung Cancer, Urothelial Carcinoma, Squamous Cell Carcinoma of Head and Neck. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04601402?

The interventions under investigation include: Avelumab (DRUG), GEN-001 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04601402?

This trial is sponsored by Genome & Company, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04601402 being conducted?

This trial has 3 study locations across Connecticut, Georgia, Oregon. 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