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Recruiting
NCT06545331
Study of XB010 in Subjects With Solid Tumors
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)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 396
Sponsor: Exelixis
Location: City of Hope Orange County Lennar Foundation Cancer Center Irvine California
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 Criteria
* 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.
Source: ClinicalTrials.gov (NCT06545331). StuddyBuddy aggregates publicly available trial information.