STELLAR-009
Research type
Research Study
Full title
A Phase 1b/2 Dose-finding and Expansion Study Evaluating the Safety and Efficacy of Zanzalintinib (XL092) Combined with Either AB521 or AB521 Plus Nivolumab in Subjects with Advanced Clear Cell Renal Cell Carcinoma or Other Advanced Solid Tumors
IRAS ID
1009547
Contact name
Anne Lester
Contact email
Sponsor organisation
Exelixis, Inc.
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to test the safety of XL092 at different dose levels when given in combination with AB521 or combination with AB521 and nivolumab. Patients participating in the clinical study of zanzalintinib (XL092) have advanced cancer, or cancer that has spread to another part of their body (also called metastatic). The most common type of cancer that we are looking at in this study is called clear cell renal cell carcinoma (ccRCC).
There are two treatment parts to the study a dose-finding stage and an expansion stage. The dose-finding Stage will be conducted in the US and the Expansion Stage will be conducted globally.
Participants will receive 1 of 2 investigational study treatments. The study treatment will be made up of 2 or 3 study drugs. The study drugs are called zanzalintinib, AB521, and nivolumab.
Approximately 140 patients will be enrolled in the study across approximately 40 sites globally. The study will take around 12 to 24 months to complete and consists of the following periods:
- Screening Period (about 28 days),
- Study Treatment Period (about 1–2 years), and a
- Post-Treatment Period (about 1 month plus further follow-up calls)
The duration of each combination study intervention will be dependent on the combination administered. Any cohort may be opened or closed to enrollment at any time at the Sponsor’s discretion.REC name
London - Surrey Borders Research Ethics Committee
REC reference
24/LO/0382
Date of REC Opinion
25 Jun 2024
REC opinion
Further Information Unfavourable Opinion