Phase 2 Liver Cancer Trial, Recruiting NCT07042919 Sponsor: Devalingam Mahalingam Condition: Liver Cancer
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Phase 2 Liver Cancer Trial, Recruiting

NCT07042919
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have a confirmed diagnosis of hepatocellular carcinoma (liver cancer) that cannot be treated with curative intent.
  • People whose liver cancer has shown clear signs of growing or spreading during or after at least one prior treatment, or who were unable to tolerate prior treatment — as long as that prior treatment did not include cabozantinib.
  • People who have received no more than two prior treatment courses for advanced or metastatic liver cancer (not counting cabozantinib; palliative radiation or local treatments to the liver do not count as a prior line of therapy).
  • People whose liver function falls into Child-Pugh class A, or Child-Pugh class B with a score of B7 or B8 (a measure of liver disease severity — confirm with trial site).
  • People whose cancer can be measured on scans according to standard criteria called RECIST v1.1 (confirm with trial site).
  • People aged 18 years or older.
  • People who are reasonably active and able to care for themselves, as measured by a standard performance scale (ECOG 0–1, or Karnofsky score of 60% or above — confirm with trial site).
  • People whose blood counts, liver function, kidney function, and other organ measurements meet the specific levels required by the trial (the trial site will check these through blood tests).
  • People who are able to swallow tablets or liquid medication, or receive it through a feeding tube if needed.
  • People who are able to understand the study, agree to its requirements, and sign a consent form.
  • People of childbearing potential, and those with sperm-producing reproductive capacity, who agree to use highly effective contraception during the study and for a specified period after the last dose of treatment (the trial site will provide details).

Who may not be able to join:

  • People who have previously been treated with the study drug, zanzalintinib.
  • People who have previously been treated with cabozantinib.
  • People who have received three or more prior treatment courses for advanced liver cancer.
  • People who have taken any small-molecule targeted therapy (including investigational drugs of that type) within 14 days before the study start date.
  • People who have received chemotherapy, immunotherapy, radiation, or other systemic cancer treatments within 4 weeks before the study start date.
  • People who have had radiation therapy to bone metastases within 14 days, or any other radiation within 4 weeks, before the study start date.
  • People who have received radioactive substance-based treatments within 6 weeks before the study start date.
  • People who have had local liver treatments — such as surgery, ablation, or chemoembolisation — within 28 days before the study start date.
  • People who still have unresolved side effects from previous cancer treatment that are grade 2 or higher in severity (except for certain conditions such as hair loss, which may be allowed — confirm with trial site).
  • People with another active cancer that has been progressing or required treatment within the past 2 years (some early-stage or fully treated skin cancers and certain other low-risk cancers may be exceptions — confirm with trial site).
  • People with brain metastases (cancer spread to the brain) that have not been adequately treated and stable for at least 28 days before the study start date (some small, stable, untreated lesions may be considered — confirm with trial site).
  • People with a known history of serious allergic reactions to drugs with a similar chemical makeup to zanzalintinib.
  • People taking certain blood-thinning or antiplatelet medications (such as warfarin or clopidogrel); some specific anticoagulants at low or stable doses may be permitted — confirm with trial site.
  • People taking herbal supplements or traditional medicines to treat their cancer within 2 weeks before the study start date (taking these for symptom relief only may be allowed — confirm with trial site).
  • People with serious uncontrolled illness or other significant medical conditions that the trial team considers unsafe.
  • People who have had significant bleeding episodes (such as coughing or vomiting blood, or other major bleeding) within the 12 weeks before joining the trial.
  • People with certain lung lesions causing symptoms, or cancer growing into major blood vessels such as the main lung artery or the aorta (some exceptions may apply — confirm with trial site).
  • People who have had major surgery within 8 weeks, keyhole (laparoscopic) surgery within 28 days, or minor surgery within 5 days before the study start date, or whose surgical wounds have not fully healed.
  • People with a heart rhythm measurement called the QTcF interval above 480 ms on a recent ECG (heart tracing) taken within 14 days before the study start date.
  • People who are pregnant or breastfeeding, as the study drug may be harmful to an unborn baby or infant.
  • People whose mental health, social circumstances, or other conditions would make it difficult to safely follow the study requirements or give informed consent, in the opinion of the treating doctor.
  • People who have had hepatic encephalopathy (confusion caused by liver failure) within 6 weeks before the study start date.
  • People with significant fluid build-up in the abdomen (ascites) that has required drainage or increased medication within 2 weeks before the study start date.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Devalingam Mahalingam, Northwestern University

Phone: 3126951301

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Devalingam Mahalingam
Registry
ClinicalTrials.gov
Start date
30 March 2026
Est. completion
4 March 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Dose-limiting toxicity (DLT) and Recommended Phase 2 Dose (Phase Ib dose-escalation only)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov