Zanzalintinib in Second Line and Beyond for the Treatment of Advanced Liver Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Devalingam Mahalingam
Study ID
NCT07042919
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Hepatocellular Carcinoma
  • Cirrhosis
  • Stage III Hepatocellular Carcinoma AJCC v8
  • Stage IV Hepatocellular Carcinoma AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo urine and blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Zanzalintinib — DRUG
    Given PO

Study Details

This phase Ib/II trial tests the safety, side effects, and best dose of zanzalintinib and how well it works in treating patients with hepatocellular (liver) cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Zanzalintinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply, which may help keep tumor cells from growing. Giving zanzalintinib may be safe, tolerable, and/or effective in treating patients with advanced liver cancer.

Key Dates

First listed
Jun 29, 2025
Start date
Mar 30, 2026
Status verified
Jun 2025
Primary completion
Mar 4, 2029
Completion
Mar 4, 2031

Study Design

Enrollment
59 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (zanzalintinib)
    Patients receive zanzalintinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo urine and blood sample collection and CT or MRI throughout the study.

Primary Outcome Measure

Dose-limiting toxicity (DLT) and Recommended Phase 2 Dose (Phase Ib dose-escalation only) [ Time Frame: Through the duration of cycle 1 (cycle length = 28 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Devalingam Mahalingam, MD, PhD
[email protected]
312-695-6929
Devalingam Mahalingam, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Northwestern University· Chicago, IL

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