A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Participation Requirements⁃ 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.
City of Hope Orange County Lennar Foundation Cancer Center
RECRUITING
Irvine
UCLA Department of Medicine - Hematology/Oncology
RECRUITING
Los Angeles
Georgetown University Medical Center
RECRUITING
Washington D.c.
Sarah Cannon Research Institute at Florida Cancer Specialists
RECRUITING
Orlando
Winship Cancer Institute
RECRUITING
Atlanta
University of Chicago Medical Center
RECRUITING
Chicago
Siteman Cancer Center
RECRUITING
St Louis
Carolina BioOncology Institute
RECRUITING
Huntersville
Montefiore Medical Center - Montefiore Medical Park
RECRUITING
The Bronx
Stephenson Cancer Center
RECRUITING
Oklahoma City
SCRI Oncology Partners
RECRUITING
Nashville
NEXT Austin
RECRUITING
Austin
Baylor University Medical Center
RECRUITING
Dallas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Inova Schar Cancer
RECRUITING
Fairfax
NEXT Virginia
RECRUITING
Fairfax
University Hospitals of Leicester NHS Trust
RECRUITING
Leicester
Sarah Cannon Research Institute London
RECRUITING
London
University College London Hospitals NHS Foundation Trust
RECRUITING
London
The Christie NHS Foundation Trust
RECRUITING
Manchester
Primary
Exelixis Clinical Trials
druginfo@exelixis.com
1-888-EXELIXIS (888-393-5494)
Backup
Backup or International
650-837-7400
Start Date: 2024-08-06
Estimated Completion Date: 2027-10-20
Target number of participants: 396
Experimental: XB010 Single-Agent Dose Escalation Cohorts
XB010 will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects
Experimental: XB010 + Pembrolizumab Dose Escalation Cohorts
XB010+Pembrolizumab will be administered at escalating dose levels every 3 weeks in cohorts of 3-12 subjects
Experimental: XB010 Single-Agent Dose Expansion Cohorts
XB010 will be administered at the recommended dose for expansion (RDE) every 3 weeks in the following tumor-specific cohorts: non-small cell lung cancer (NSCLC), hormone-receptor-positive breast cancer (HR+BC), head and neck squamous cell cancer (HNSCC), esophageal squamous cell cancer (ESCC), endometrial cancer (EC) and triple-negative breast cancer (TNBC)