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NCT04064359 · ClinicalTrials.gov registry record · Phase 1

Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors

A Phase 1 study of Solid Tumor, sponsored by Oxford BioTherapeutics.

Recruiting
Registry status
Phase 1
Development phase
200
Enrollment target
20
Study locations

NCT04064359 is a Phase 1 study of Solid Tumor that is actively recruiting participants, run by Oxford BioTherapeutics. The registered enrollment target is 200 participants, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT04064359, a Phase 1 study of Solid Tumor, is actively recruiting participants, sponsored by Oxford BioTherapeutics.

RECRUITING
Registry status
Phase 1
Development phase
200 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate OBT076, which is a drug that combines an antibody with an anti-cancer drug. This class of drugs are called Antibody-Drug Conjugates (ADC). Antibodies are normally produced in the human body by the immune system to fight infections but can be designed to target cancer cells and deliver an anti-cancer drug. OBT076 is composed of an antibody that targets the CD205 protein on cancer cells and delivers an anti-cancer drug which can kill them. OBT076 is an "Investigational Drug", which means that it is still being studied and has not yet been approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other regulatory authorities to be prescribed by doctors for the treatment of metastatic or recurrent solid tumors. The use of OBT076 in this study is investigational. This is a Phase I research study designed to look at several dose levels of the study drug to find the highest dose level that is safe and well-tolerated (does not cause unacceptable side effects), and to examine the effects of the study drug in a small group of research participants. The study will also look at the effectiveness of OBT076 as an anti-cancer therapy. Once the optimal dose is determined and safety is assessed, additional research participants will be treated at the optimal dose level to further evaluate safety and effectiveness.

Conditions Studied

Solid Tumor

Interventions

  • DRUG OBT076, a CD205-directed antibody-drug conjugate

Study Locations (20)

Other

  • Institut Jules Bordet - Brussels
  • AZ Groeninge - Kortrijk
  • Institut Paoli Calmettes - Marseille
  • GHP Saint-Joseph - Paris
  • Hopital Saint Antoine - Paris
  • Hopital Saint Louis - Paris
  • Centre Eugène Marquis - Rennes
  • ICANS - Institut de cancérologie Strasbourg - Strasbourg
  • Institut Gustave Roussy - IGR - Villejuif

California

  • Cedars-Sinai - Los Angeles
  • UCLA - Santa Monica

Arizona

  • Mayo Clinic - Phoenix

Florida

  • Moffitt Cancer Center - Tampa

Iowa

  • The State University of Iowa - Iowa City

Kentucky

  • St. Elizabeth Healthcare - Edgewood

Mississippi

  • University of Mississippi Medical Center - Jackson

New Mexico

  • Quantum Santa Fe - Santa Fe

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2019-07-25
Est. Completion 2027-12-31
Phase Phase 1

Sponsor

Oxford BioTherapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04064359

The ClinicalTrials.gov registry entry for NCT04064359 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (10% lower). The listed sponsor is Oxford BioTherapeutics, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which OBT076, a CD205-directed antibody-drug conjugate is the first listed.

NCT04064359 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT04064359 about?

NCT04064359 is a clinical study titled "Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors". The purpose of this study is to evaluate OBT076, which is a drug that combines an antibody with an anti-cancer drug. This class of drugs are called Antibody-Drug Conjugates (ADC). Antibodies are normally produced in the human body by the immune system to fight infections but can be designed to targe...

What is the current status of trial NCT04064359?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2019-07-25. Estimated completion is 2027-12-31.

What conditions does trial NCT04064359 study?

This clinical trial studies the following conditions: Solid Tumor.

What interventions are being tested in trial NCT04064359?

The interventions under investigation include: OBT076, a CD205-directed antibody-drug conjugate (DRUG).

Who is sponsoring clinical trial NCT04064359?

This trial is sponsored by Oxford BioTherapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04064359 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Iowa, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.