RecruitingPhase 1NCT03715933

Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

Sponsor

Inhibrx Biosciences, Inc

Enrollment

321 participants

Start Date

Oct 8, 2018

Study Type

INTERVENTIONAL

Conditions

Ewing Sarcoma

Summary

This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).

Eligibility

Min Age: 12 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called INBRX-109 — alone or in combination with other therapies — in patients with advanced solid tumors that have stopped responding to other treatments, with a special focus on Ewing sarcoma (a bone and soft tissue cancer) and colorectal cancer. **You may be eligible if...** - You are between 12 and 85 years old (for Ewing sarcoma) or 18 to 85 years old (for other cancers) - You have advanced or metastatic Ewing sarcoma that has relapsed or stopped responding to 1–2 prior treatments, OR advanced colorectal cancer that has failed 2–3 prior treatments - Your cancer can be measured on scans - You are well enough to carry out most daily activities (ECOG 0 or 1, or Karnofsky/Lansky score at or above 60) - Your life expectancy is at least 12 weeks - Tumor tissue is available for testing **You may NOT be eligible if...** - You have previously received a drug in the DR5 agonist class - You have had recent anti-cancer therapy within 4 weeks (or 5 half-lives) before starting the trial - You have a blood cancer - You are allergic to INBRX-109 or similar antibodies - You are pregnant or breastfeeding - You have had a bone marrow transplant within the last 5 years Talk to your doctor to see if this trial is right for you.

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

DRUGINBRX-109

Tetravalent DR5 Agonist Antibody

DRUGIrinotecan

Chemotherapy

DRUGTemozolomide

Chemotherapy

DRUGcarboplatin

chemotherapy

DRUGpemetrexed

chemotherapy

DRUGLeucovorin

chemotherapy

DRUGFluorouracil

chemotherapy

Locations(35)

HonorHealth Research Institute

Scottsdale, Arizona, United States

Precision NextGen Oncology and Research

Beverly Hills, California, United States

City of Hope

Duarte, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

University of California, San Diego (UCSD) - Moores Cancer Center

San Diego, California, United States

University of California, San Francisco (UCSF)

San Francisco, California, United States

Sarcoma Oncology Center

Santa Monica, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Emory University - Winship Cancer Institute

Atlanta, Georgia, United States

The University of Chicago

Chicago, Illinois, United States

University of Michigan

Ann Arbor, Michigan, United States

START Midwest Michigan, PC

Grand Rapids, Michigan, United States

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Children's Hospital of Philadelphia- Center for Childhood Cancer Research

Philadelphia, Pennsylvania, United States

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Vanderbilt University School of Medicine

Nashville, Tennessee, United States

UT MD Anderson Cancer Center

Houston, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

NEXT Oncology - Virginia

Fairfax, Virginia, United States

Centre Leon Berard

Lyon, France

Gustave Roussy

Villejuif, France

La Fondazione e l'Istituto di Candiolo

Candiolo, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

University Medical Center Groningen

Groningen, Netherlands

Academisch Ziekenhuis Leiden

Leiden, Netherlands

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Clinico San Carlos

Madrid, Spain

Great North Children's Hospital

London, United Kingdom

University College London Hospital

London, United Kingdom

The Royal Marsden NHS Foundation Trust

London, United Kingdom

Royal Manchester Children's Hospital

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT03715933

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