Zanzalintinib, Durvalumab, and Tremelimumab for Unresectable Liver Cancer
This study is testing a new combination of medicines for people with liver cancer (hepatocellular carcinoma) that cannot be removed by surgery. The study will investigate if Zanzalintinib, a drug that targets certain proteins (tyrosine kinase inhibitor), works well when combined with Durvalumab and Tremelimumab, which are immunotherapies that help your body's immune system fight cancer. To join, you must have unresectable liver cancer and not have received prior systemic treatment for it. Researchers will measure how many people respond to the treatment (Objective Response Rate) and determine the best dose for future studies. The study aims to enroll 40 participants.
- Study design
- This is an interventional study with a planned enrollment of 40 participants. It includes a safety lead-in phase to determine the recommended dose.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will measure objective response for up to 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Zanzalintinib (XL-092) Plus Durvalumab and Tremelimumab in Unresectable Hepatocellular Carcinoma (ZENOBIA)
At a glance
Conditions
NCT06698250
Where you'd take part
This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Houston Methodist Neal Cancer Center
Houston, Texasstudy coordinator listed
Not yet recruiting
Mays Cancer Center, UT Health San Antonio
San Antonio, Texasstudy coordinator listed
Not yet recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvaniastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Anwaar M Saeed, MD · PRINCIPAL_INVESTIGATOR · UPMC Hillman Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Recommended phase 2 dose (RP2D) of XL-092 with Durvalumab plus TremelimumabUp to 12 months
Recommended phase 2 dose (RP2D) of XL-092 with Durvalumab plus Tremelimumab will be determined per a Dose Limiting Toxicity period of 28 days during the Safety Lead-in period using CTCAE v5.0 criteria.
- Objective Response Rate (ORR) (im RECIST)Up to 24 months
Proportion of patients with Complete Response (CR) or Partial Response (PR), per immune modified RECIST v1.1. Per imRECIST: CR: -100% Change in Sum of Diameters from Baseline (non-target lesion). PR: ≤ -30% change in sum of diameters from baseline.