RecruitingPhase 1NCT06545331

Study of XB010 in Subjects With Solid Tumors

A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors

Sponsor

Exelixis

Enrollment

396 participants

Start Date

Aug 6, 2024

Study Type

INTERVENTIONAL

Conditions

Hormone Receptor-Positive Breast Cancer Locally Advanced or Metastatic Solid Tumors Triple Negative Breast Cancer(TNBC)NSCLC (Non-small Cell Lung Cancer)Esophageal Squamous Cell Cancer Head and Neck Squamous Cell Cancer

Summary

This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called XB010 in people with solid tumors — cancers that form lumps in the body, as opposed to blood cancers — including lung cancer, breast cancer, head and neck cancer, esophageal cancer, and triple-negative breast cancer. **You may be eligible if...** - You are 18 or older with a confirmed advanced, metastatic, or recurrent solid tumor that cannot be surgically removed - Your cancer type is one of: non-small cell lung cancer, hormone receptor-positive breast cancer, head and neck cancer, esophageal squamous cell carcinoma, or triple-negative breast cancer - You are in good physical condition (ECOG 0–1) with adequate organ function **You may NOT be eligible if...** - You have poor organ function (liver, kidneys, blood counts) - You are unable to comply with the study schedule - You have a serious active infection or other uncontrolled condition 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

DRUGXB010

IV administration of XB010

DRUGPembrolizumab

IV administration of Pembrolizumab

Locations(20)

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States

UCLA Department of Medicine - Hematology/Oncology

Los Angeles, California, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, United States

Winship Cancer Institute

Atlanta, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Siteman Cancer Center

St Louis, Missouri, United States

Montefiore Medical Center - Montefiore Medical Park

The Bronx, New York, United States

Carolina BioOncology Institute

Huntersville, North Carolina, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

NEXT Austin

Austin, Texas, United States

Baylor University Medical Center

Dallas, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Inova Schar Cancer

Fairfax, Virginia, United States

NEXT Virginia

Fairfax, Virginia, United States

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Sarah Cannon Research Institute London

London, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06545331

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