Zanzalintinib + Immunotherapy for Liver Cancer
(ZENOBIA Trial)
Trial Summary
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it does require stopping certain treatments like oral anticoagulants and complementary medications at least 2 weeks before starting the study. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination Zanzalintinib, Durvalumab, and Tremelimumab for liver cancer?
The combination of durvalumab and tremelimumab has shown clinical benefits and a tolerable safety profile in patients with solid tumors, including liver cancer. Additionally, tremelimumab combined with durvalumab has been approved for treating unresectable hepatocellular carcinoma, indicating its effectiveness in liver cancer.12345
Is the combination of Zanzalintinib, Durvalumab, and Tremelimumab safe for humans?
The combination of Durvalumab and Tremelimumab has been shown to have a tolerable safety profile in patients with solid tumors, including liver cancer. Common side effects include rash, fatigue, diarrhea, itching, muscle pain, and abdominal pain. Serious side effects occurred in about 32.6% of patients, which is higher than when using Durvalumab alone.23467
What makes the drug combination of Zanzalintinib, Durvalumab, and Tremelimumab unique for liver cancer?
This drug combination is unique because it combines Zanzalintinib, a novel agent, with Durvalumab and Tremelimumab, which are immune checkpoint inhibitors that help the immune system attack cancer cells. This approach is different from standard treatments as it targets the cancer in multiple ways, potentially improving effectiveness for patients with advanced liver cancer.12358
Eligibility Criteria
This trial is for individuals with unresectable hepatocellular carcinoma (HCC), which is a type of liver cancer that cannot be removed by surgery. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and have no conflicting conditions.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Safety Lead-in
Safety lead-in to define the Recommended Phase 2 Dose (RP2D) with dose escalation or de-escalation
Treatment
Participants receive Zanzalintinib (XL-092) in combination with Durvalumab and Tremelimumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Durvalumab (Checkpoint Inhibitor)
- Tremelimumab (Checkpoint Inhibitor)
- Zanzalintinib (Other)
Durvalumab is already approved in European Union, United States, Japan for the following indications:
- Locally advanced, unresectable non-small cell lung cancer (NSCLC)
- Extensive-stage small cell lung cancer (ES-SCLC)
- Limited-stage small cell lung cancer (LS-SCLC)
- Locally advanced or metastatic urothelial carcinoma
- Not specified in provided sources