A Dose-Escalation and Expansion Study of XB010 in Subjects with Solid Tumours

  • Research type

    Research Study

  • Full 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

  • IRAS ID

    1012465

  • Contact name

    Ronald Bernardi

  • Contact email

    rbernardi@exelixis.com

  • Sponsor organisation

    Exelixis, Inc.

  • Clinicaltrials.gov Identifier

    NCT06545331

  • Research summary

    This is an open label study that is designed to establish if XB010 (a study medication or an “investigational” medication) is safe, effective and well tolerated when it is administered either alone or with another medication called pembrolizumab. Exelixis, Inc. (“Sponsor”) is conducting the study of XB010 in participants with advanced or metastatic solid cancerous tumours. “Investigational” means that XB010 has not been approved by any Regulatory Agency (for example, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) for use as a prescription medication.
    Approximately 260 participants are expected to take part in this study worldwide, with approximately 18 participants from the UK.
    Over a period of approximately 2 years participants in this study will be required to attend the study site/hospital to receive the medication every three weeks via an intravenous (IV) infusion. They will undergo some procedures including blood and urine tests, physical examinations, eye examinations, tests to see how well their heart is working (ECG) and scans to assess how the medication is affecting their tumour. All of the tests are required to assess how well participants are responding to the medication and to make sure they are safe and well.

  • REC name

    London - Riverside Research Ethics Committee

  • REC reference

    25/LO/0639

  • Date of REC Opinion

    23 Sep 2025

  • REC opinion

    Further Information Favourable Opinion