Study of XL092 in Combination with Immuno-Oncology Agents in Subject with Solid Tumors (STELLAR-002)
Research type
Research Study
Full title
A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination with Immuno-Oncology Agents in Subjects with Unresectable Advanced or Metastatic Solid Tumors
IRAS ID
1005226
Contact name
Anne Lester
Contact email
Sponsor organisation
Exelixis, Inc.
Eudract number
2021-004855-18
Clinicaltrials.gov Identifier
Research summary
The purpose of the study is to determine recommended dose for potential new anticancer therapies for people diagnosed with advanced solid tumours in the first part of the study (escalation stage). The second part (expansion stage) will enrol patients with solid tumours in kidney cancer, metastatic prostate cancer, bladder cancer.
This study includes 2 stages: Dose-Escalation Stage and Cohort-Expansion Stage. Participants in the UK only participate in the Cohort-Expansion stage with Single-Agent or Combination Therapy dosing. In the Single-Agent dosing schedule, patients receive XL092 alone.
In the Combination dosing schedule, participants may receive either:
XL092 in combo with Nivolumab (doublet), XL092 in combo with Nivolumab + Ipilimumab (triplet), Nivolumab + Ipilimumab (doublet)
Patients take part in tumour types shown based on cancer populations: clear cell renal cell carcinoma (ccRCC, first- [Cohort 1] and second-line [Cohort 2]), metastatic castration-resistant prostate cancer (mCRPC, second-line post-novel hormonal therapy [NHT], Cohort 3), urothelial carcinoma (UC, ICI-naïve [Cohort 4] and ICI-experienced [Cohort 5]), and non-clear cell renal cell carcinoma (nccRCC, first-line, Cohort 6).
Patient will receive study treatment as long as they continue to experience clinical benefit in the opinion of the Investigator or until unacceptable toxicity, need for subsequent systemic anticancer treatment, or until other reasons for treatment discontinuation in the protocol. Nivolumab treatment is limited to maximum duration of 2 yrs (based on time since first dose of study treatment), and ipilimumab treatment is limited to maximum of 4 doses. There is no maximum treatment duration for XL092 if the patient has not experienced a loss of clinical benefit or met a discontinuation criterion per protocol.
This study is conducted in the UK, EU, Australia, New Zealand, Israel, Switzerland, Canada, US: sponsored by pharmaceutical company Exelixis, Inc.REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/LO/0641
Date of REC Opinion
15 Nov 2022
REC opinion
Further Information Favourable Opinion