What this study is
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.
What's being tested
- XB010
Intervention · DRUG
IV administration of XB010
- Pembrolizumab
Intervention · DRUG
IV administration of Pembrolizumab
Study details
- Official title
- 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
- Conditions
- Locally Advanced or Metastatic Solid Tumors · Esophageal Squamous Cell Cancer · Head and Neck Squamous Cell Cancer · NSCLC (Non-small Cell Lung Cancer) · Hormone-receptor-positive Breast Cancer · Triple Negative Breast Cancer (TNBC)
- Enrolling
- 396 people
- Starts
- 2024-08-06
- Est. completion
- 2027-10-20
- Design
- Open-label, non-randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (20)
18 openCity of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
RecruitingUCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, United States
RecruitingSarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States
RecruitingWinship Cancer Institute
Atlanta, Georgia, United States
RecruitingUniversity of Chicago Medical Center
Chicago, Illinois, United States
RecruitingSiteman Cancer Center
St Louis, Missouri, United States
RecruitingMontefiore Medical Center - Montefiore Medical Park
The Bronx, New York, United States
RecruitingStephenson Cancer Center
Oklahoma City, Oklahoma, United States
RecruitingSCRI Oncology Partners
Nashville, Tennessee, United States
RecruitingNEXT Austin
Austin, Texas, United States
RecruitingBaylor University Medical Center
Dallas, Texas, United States
RecruitingUniversity of Texas MD Anderson Cancer Center
Houston, Texas, United States
RecruitingInova Schar Cancer
Fairfax, Virginia, United States
RecruitingNEXT Virginia
Fairfax, Virginia, United States
RecruitingGeorgetown University Medical Center
Washington D.C., District of Columbia, United States
CompletedCarolina BioOncology Institute
Huntersville, North Carolina, United States
Completed
4 sites outside the US
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
RecruitingSarah Cannon Research Institute London
London, United Kingdom
RecruitingUniversity College London Hospitals NHS Foundation Trust
London, United Kingdom
RecruitingThe Christie NHS Foundation Trust
Manchester, United Kingdom
Recruiting
Study team
Sponsor
Exelixis
Study ID XB010-101
Study director
Study Director
Exelixis
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.