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
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
Inclusion Criteria6
- 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
DRUGXB010
IV administration of XB010
DRUGPembrolizumab
IV administration of Pembrolizumab
Locations(17)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06545331
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