*A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumours

• Research type

  Research Study

• Full title

  A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors

• IRAS ID

  1003785

• Contact name

  Mary Liu

• Contact email

  mliu@exelixis.com

• Sponsor organisation

  Exelixis, Inc.

• Eudract number

  2020-003569-21

• Clinicaltrials.gov Identifier

  NCT03845166

• Research summary

  The purpose of this Phase 1, first-in-human study is to learn about the effects of the study medication XL092 as a single-agent, in combination with atezolizumab, and in combination with avelumab. The study will enrol participants with advanced solid tumours, who have already received standard treatments for their cancer and their cancer has gotten worse or returned after their last treatment. This study aims to test the safety, the ability of the participant’s body to accept the study medication(s), to measure the study medication(s) and/or its break-down products levels in their blood, and how their body reacts to the study medication(s). Different dose levels of XL092 will be tested so that a tolerable dose for treating cancer can be found.

  This study includes two stages: a Dose-Escalation Stage and a Cohort-Expansion Stage to study. Participants in the UK will only participate in the Cohort-Expansion stage involving a Single-Agent or Combination Therapy dosing schedule. In the Single-Agent therapy dosing schedule, participants will receive XL092 alone. In the Combination Therapy dosing schedule, participants may receive either:
  - XL092 alone or in combination with Atezolizumab
  - XL092 alone or in combination with Avelumab

  Additionally, a limited number of participants will be enrolled in biomarker cohorts to evaluate the pharmacodynamic effects of XL092 as single-agent therapy and in combination therapy.

  Participants may receive study treatment for up to 2 years depending on their ability to safely tolerate the treatment, their response to treatment and their and their doctor’s decision to continue treatment. Tests and procedures involved are: physical examinations, electrocardiograms (ECG), collection of blood, urine and tumour samples (including optional research blood samples), tumour scans, among others.

  This study is conducted in the UK, EU, Australia and US. It is sponsored by the pharmaceutical company Exelixis, Inc.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  22/SC/0278

• Date of REC Opinion

  2 Aug 2021

• REC opinion

  Further Information Favourable Opinion