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NCT06545331PHASE1Recruiting

Study of XB010 in Subjects With Solid Tumors

Exelixis

Start Date

8/6/2024

Completion Date

10/20/2027

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.

Detailed Description

This study consists of Dose-Escalation and Cohort-Expansion Stages. The Dose-Escalation Stage is designed to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE\[s\]) of XB010 as a single agent, and to evaluate XB010 monotherapy RDE(s) in combination with pembrolizumab. The Cohort-Expansion Stage is designed to explore the clinical activity and further characterize the safety and tolerability of XB010 as monotherapy in multiple tumor-specific cohorts.

Eligibility Criteria

Age Range: 18 years to No maximum

* Age 18 years or older on the day of consent. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. * Adequate organ and marrow function. * Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent. * The Cohort Expansion stage will enroll subjects with multiple tumor types (non-small cell lung cancer, hormone-receptor-positive breast cancer, head and neck cancer, esophageal squamous cell, triple-negative breast cancer). * Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.

Interventions

DRUG

XB010

DRUG

Pembrolizumab

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Conditions

Locally Advanced or Metastatic Solid TumorsEsophageal Squamous Cell CancerHead and Neck Squamous Cell CancerNSCLC (Non-small Cell Lung Cancer)Hormone-receptor-positive Breast CancerTriple Negative Breast Cancer (TNBC)

Locations

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California 91010

United States

UCLA Department of Medicine - Hematology/Oncology

Los Angeles, California 90095

United States

Georgetown University Medical Center

Washington D.C., District of Columbia 20007

United States

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida 32827

United States

Winship Cancer Institute

Atlanta, Georgia 30322

United States

University of Chicago Medical Center

Chicago, Illinois 60637

United States

Siteman Cancer Center

St Louis, Missouri 63110

United States

Montefiore Medical Center - Montefiore Medical Park

The Bronx, New York 10461

United States

Carolina BioOncology Institute

Huntersville, North Carolina 28078

United States

Stephenson Cancer Center

Oklahoma City, Oklahoma 73104

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

NEXT Austin

Austin, Texas 78758

United States

Baylor University Medical Center

Dallas, Texas 75246

United States

University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Inova Schar Cancer

Fairfax, Virginia 22031

United States

NEXT Virginia

Fairfax, Virginia 22031

United States

University Hospitals of Leicester NHS Trust

Leicester, LE1 5WW

United Kingdom

Sarah Cannon Research Institute London

London, W1G 6AD

United Kingdom

University College London Hospitals NHS Foundation Trust

London, W1T 7HA

United Kingdom

The Christie NHS Foundation Trust

Manchester, M20 4BX

United Kingdom