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Safety Lead-in - Zanzalintinib (XL-092) + Tremelimumab (IV) + Durvalumab (IV) for Liver Cancer (ZENOBIA Trial)

Phase 2

Waitlist Available

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

1. Patients must have unresectable hepatocellular carcinoma.

2. Patients must be treatment naïve for systemic therapy in the unresectable setting.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 40 months

Awards & highlights

No Placebo-Only Group

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).

Eligible Conditions

Liver Cancer

Eligibility Criteria

Inclusion Criteria

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

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

Tremelimumab

2017

Completed Phase 2

~3070

Durvalumab

2017

Completed Phase 2

~3750