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Epigenetic drug may re-sensitize liver tumors to immunotherapy

NCT ID NCT05873244

Disease control Sponsor: Stephen Chan Lam Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial investigates whether adding an epigenetic drug (CXD101) to an immunotherapy (Geptanolimab) can help patients with advanced liver cancer whose disease has stopped responding to prior checkpoint inhibitors. The study enrolls about 26 adults with hepatocellular carcinoma who have previously received immunotherapy. Participants receive either the combination therapy or a standard targeted therapy (lenvatinib or sorafenib). The main goal is to see if the combination improves progression-free survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Zabadinostat (CXD101) and Geptanolimab
What this could lead to
If successful, this combination could offer a new treatment option for liver cancer patients whose tumors have stopped responding to standard immunotherapy.
What could go wrong
This is a small, early-phase proof-of-concept trial with only 26 participants. The approach may not work in a larger, more diverse group, and side effects from the drug combination are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

26 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of HCC according to the AASLD guideline20 * Prior treatment with systemic treatment consisting of immune checkpoint inhibitors (anti-PD1, anti-PDL1 or anti-CTLA4) * The duration of previous ICI must be 6 weeks or longer to avoid chance of pseudo-progression * Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1 * Adequate hematological function: * Absolute neutrophil count (ANC) ≥ 1.5 x109/L; Platelets ≥ 100 x 109/L and Hemoglobin ≥ 8g/dL * Adequate renal function: * Urine protein/creatinine ratio ≤ 1 mg/mg (≤ 113.1 mg/mmol) or 24-hour urine protein \< 1g * Serum creatinine ≤ 1.5 × upper limit of normal or calculated creatinine clearance ≥ 40 mL/min (according to the Cockcroft-Gault equation) * Adequate hepatic function parameters: * Total bilirubin ≤ 2 mg/dL (≤ 34.2 μmol/L) * Serum albumin ≥ 2.8 g/dL (≥ 28 g/L) * Alanine aminotransferase (ALT) \< 3.0 upper limit of normal (ULN) Exclusion Criteria: * Previous development of severe autoimmune complications from immune checkpoint inhibitors * History of moderate to sever autoimmune disease requiring steroid use * History of organ transplant * Prior use of lenvatinib or sorafenib * Disease involvement/thrombosis of major vessels (including main trunk of portal vein, inferior vena cava or pulmonary artery) * More than two lines of systemic therapy (i.e., study treatment must be second-line or third-line treatment) * Clinically significant bleeding events (eg.. esophageal varices) within 3 months * Moderate or severe ascites * Child-pugh B or C hepatic function * Systolic blood pressure of 200mmHg or higher * Pregnant or lactating females

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HCC

Contacts and locations

Locations

  • Department of Clinical Oncology, Prince of Wales Hospital

    Hong Kong, Hong Kong

  • School of Biomedical Science, The Chinese University of Hong Kong

    Hong Kong, Hong Kong

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