Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-27 @ 9:39 AM
Study NCT ID:
NCT06698250
Status:
RECRUITING
Last Update Posted:
2025-11-06
First Post:
2024-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zanzalintinib (XL-092) Plus Durvalumab and Tremelimumab in Unresectable Hepatocellular Carcinoma (ZENOBIA)
Sponsor:
Anwaar Saeed
Organization:
Study Overview
Official Title:
Phase II Trial of Zanzalintinib (XL-092) in Combination With Durvalumab Plus Tremelimumab in Unresectable Hepatocellular Carcinoma (ZENOBIA)
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZENOBIA
Brief Summary:
This study will investigate if modulating the tumor microenvironment with biologic agents like XL-092 will have synergistic effect when combined with checkpoint based immunotherapeutic treatment of patients with hepatocellular carcinoma (HCC).
Detailed Description:
Zanzalintinib (XL-092) is a next generation tyrosine kinase inhibitor (TKI) with the target inhibition profile identical to cabozantinib but with a superior pharmacokinetic profile. As cabozantinib targets multiple tyrosine kinases, including vascular endothelial growth factor receptor (VEGFR), MET proto-oncogene, receptor tyrosine kinase (MET), and AXL receptor tyrosine kinase (AXL), and has been reported to show immunomodulatory properties that may counteract tumor-induced immunosuppression, XL-092 is expected to have similar immune modulatory activity, providing a rationale for combining it with PD-1 or PD-L1 inhibitors. This study asserts the belief that modulating the tumor microenvironment with biologic agents like XL-092 will have synergistic effect when combined with checkpoint based immunotherapeutics like durvalumab and tremelimumab in patients with hepatocellular carcinoma (HCC). There will be a Safety lead-in to define the Recommended Phase 2 Dose (RP2D) that will enroll 6-12 patients.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| XL092- IST207 | OTHER | Exelixis Protocol Number | View |