RecruitingPhase 1NCT04064359

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

A Phase I, Open-label, Dose Finding Study to Assess the Safety, Tolerability, PK, and Preliminary Efficacy of OBT076, a CD205-directed ADC, in Recurrent and/or Metastatic CD205+ Solid Tumors


Sponsor

Oxford BioTherapeutics Ltd

Enrollment

200 participants

Start Date

Jul 25, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying OBT076, a CD205-directed antibody-drug conjugate for people with solid tumor. The study is currently recruiting participants at 27 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOBT076, a CD205-directed antibody-drug conjugate

Intravenous (IV) infusion of OBT076 every 3 weeks.


Locations(27)

Mayo Clinic

Phoenix, Arizona, United States

Cedars-Sinai

Los Angeles, California, United States

UCLA

Santa Monica, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

The State University of Iowa

Iowa City, Iowa, United States

St. Elizabeth Healthcare

Edgewood, Kentucky, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Quantum Santa Fe

Santa Fe, New Mexico, United States

Columbia University Medical Center

New York, New York, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Institut Jules Bordet

Brussels, Belgium

AZ Groeninge

Kortrijk, Belgium

Institut Paoli Calmettes

Marseille, France

GHP Saint-Joseph

Paris, France

Hopital Saint Antoine

Paris, France

Hopital Saint Louis

Paris, France

Centre Eugène Marquis

Rennes, France

ICANS - Institut de cancérologie Strasbourg

Strasbourg, France

Institut Gustave Roussy - IGR

Villejuif, France

University General Hospital Attikon

Chaïdári, Athens, Greece

Metropolitan Hospital

Athens, Greece

Sotiria General Hospital

Athens, Greece

University General Hospital of Heraklion

Heraklion, Greece

EuroMedica

Thessaloniki, Greece

START Barcelona HM Nou Delfos

Barcelona, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

University Hospital Marqués de Valdecilla

Santander, Spain

View Full Details on ClinicalTrials.gov

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NCT04064359


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