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Checkpoint Inhibitor

Zanzalintinib + Immunotherapy for Liver Cancer (ZENOBIA Trial)

Phase 2

Recruiting

Led By Anwaar M Saeed, MD

Research Sponsored by Anwaar Saeed

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Urine protein-to-creatinine ratio (UPCR) must be ≤ 1 mg/mg (≤ 113.2 mg/mmol) creatinine. Tumor tissue fresh biopsies are REQUIRED for ALL study participants at screening/baseline unless an archival tumor tissue block is available and fulfills the criteria.

Patients must have unresectable hepatocellular carcinoma.

Must not have

History of specific pulmonary conditions or evidence of active pneumonitis.

Child Pugh score > 7.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 40 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at whether using a drug called XL-092 along with immunotherapy can help treat liver cancer more effectively.

Who is the study for?

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.

What is being tested?

The study tests the combination of Zanzalintinib (XL-092) with two immunotherapy drugs, Durvalumab and Tremelimumab, to see if they work better together in treating liver cancer by modifying the tumor environment.

What are the potential side effects?

Potential side effects may include immune-related reactions due to checkpoint inhibitors like Durvalumab and Tremelimumab, as well as any unknown risks associated with Zanzalintinib. These can range from mild skin reactions to more serious organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver cancer cannot be removed with surgery.

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I am 18 or older and can care for myself with minimal assistance.

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I am using effective birth control methods if I'm sexually active.

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I have not received any systemic therapy for my condition that cannot be surgically removed.

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I am not pregnant and can become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of lung conditions or currently have lung inflammation.

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My liver function is severely impaired.

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I have recently had radiation therapy or treatment with radioactive substances.

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I am taking blood thinners.

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I do not have ongoing infections, non-healing wounds, digestive issues, liver problems, or need dialysis.

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I cannot swallow pills.

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I have an autoimmune disease treated with long-term immunosuppressants.

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I have an immune system disorder or have recently been on steroids.

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I have had liver-related brain issues or significant fluid in my abdomen recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 40 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 40 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 40 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) (im RECIST)

Recommended phase 2 dose (RP2D) of XL-092 with Durvalumab plus Tremelimumab

Secondary study objectives

12-month Overall Survival (OS)

24-month Overall Survival (OS)

36-month Overall Survival (OS)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Safety Lead-in - Zanzalintinib (XL-092) + Tremelimumab (IV) + Durvalumab (IV)Experimental Treatment3 Interventions

Safety Lead-in: XL-092: Dose escalation or de-escalation - Level 1 = 100 mg; Level 0 = 60 mg; Level -1 = 40 mg. The ﬁrst dose level (dose level 0) will follow the rolling 6 design. Starting with cycle 1 then cycle 3 and subsequent cycles, participants will receive XL-092 60 mg orally (PO) once daily on days 1 through 28 of every 28-day cycle. Durvalumab: Flat dose of 1500 mg intravenously (IV) Infusion on day 1 of every 28-day cycle. Dosing will start with cycle 2; Tremelimumab (IV): One priming dose of 300 mg IV infusion. The dose will be given with cycle 2 day 1

Group II: Zanzalintinib (XL-092) + Durvalumab (IV) + Tremelimumab (IV) (First Cyle Durvalumab + Tremelimumab)Active Control3 Interventions

Phase 2: XL092 dose as determined by results of safety lead-in phase orally (PO). Once daily on days 1 - 28 of every 28-day cycle. Dosing will start with cycle 2. Durvalumab: Flat dose of 1500 mg intravenously (IV) Infusion on day 1 of every 28-day cycle. Dosing will start with cycle 1. Tremelimumab (IV): One priming dose of 300 mg IV infusion. The dose will be given with cycle 1 day 1

Group III: Zanzalintinib (XL-092) + Tremelimumab (IV) + Durvalumab (IV) (First Cyle Zanzalintinib)Active Control3 Interventions

Phase 2: XL092 dose as determined by results of safety lead-in phase orally (PO). Once daily on days 1 - 28 of every 28-day cycle. Dosing will start with cycle 1 then cycle 3 and subsequent cycles. Durvalumab: Flat dose of 1500 mg intravenously (IV) Infusion on day 1 of every 28-day cycle. Dosing will start with cycle 2; Tremelimumab (IV): One priming dose of 300 mg IV infusion. The dose will be given with cycle 2 day 1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3750

Tremelimumab

2017

Completed Phase 2

~3070