XB010-101: A DOSE-ESCALATION AND EXPANSION STUDY OF XB010 AS A SINGLE AGENT AND COMBINATION THERAPY IN SUBJECTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

XB010 is an antibody-drug conjugate (ADC) targeting 5T4 with a monomethyl auristatin E (MMAE)
payload. ADCs and immune checkpoint inhibitors (ICIs) have shown efficacy in the treatment of
various cancers as monotherapies and in ADC-ICI combinations. Because of the potential of
pembrolizumab to enhance the anticancer effect of XB010, combination therapy with pembrolizumab
may also be explored:

• To evaluate safety, tolerability, and determine the MTD and/or RDE(s) of XB010 study drug. 
• To characterize PK of XB010
• To assess the immunogenicity of XB010

For more information, visit https://clinicaltrials.gov/study/NCT06545331

Inova Schar Cancer
8081 Innovation Park Drive
Fairfax, VA 22031

• Subject-disease characteristics:
  • The subject has a cytologically or histologically and radiologically confirmed solid tumor that is unresectable or metastatic and for which standard curative measures do not exist or are no longer effective, and there are no known therapies to prolong survival.
  • The subject has received at least one systemic standard life-prolonging therapy unless it does not exist, or available therapies are intolerable or no longer effective.
• Cohort-Expansion Stage Cohorts only: The subject must have measurable disease per RECIST v1.1 as determined by the Investigator.
• Age 18 years or older on the day of consent.
• Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.
• Sexually active fertile subjects and their partners must agree to highly effective methods of contraception.
• People of childbearing potential must not be pregnant at screening. 

• Radiation therapy within 2 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.\
• Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Subjects with leptomeningeal disease are not eligible.
• Positive hepatitis B surface antigen (HBsAg) test, or positive hepatitis C virus (HCV) antibody test, and HIV testing.
• History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.
• Previously identified allergy or hypersensitivity to components of the study treatment formulations.
• Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy.