Clinical Trials for Liver Cancer

Phase 1/2 Randomized, Controlled, Open-label Trial of Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ Unresectable Hepatocellular Carcinoma (HCC)

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with previously treated unresectable HCC (BCLC C or B not suitable for locoregional therapy), Child-Pugh A, ECOG 0-1, and measurable disease undergo RYZ811 gallium-68 PET to identify GPC3-positive tumors. Eligible patients receive RYZ801, an actinium-225 GPC3-targeted alpha-emitting radiopharmaceutical, with dose escalation/expansion and randomized comparison against standard-of-care systemic therapy.

ClinicalTrials.gov ID: NCT06726161

A Pilot Study of a DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Fibrolamellar Hepatocellular Carcinoma

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: For patients ≥12 years with unresectable/metastatic fibrolamellar hepatocellular carcinoma or adults with other solid tumors harboring the DNAJB1‑PRKACA fusion, including checkpoint‑naïve and some checkpoint‑experienced FLC cohorts. Treatment combines an off‑the‑shelf DNAJB1‑PRKACA junction neoepitope peptide vaccine (adjuvanted with TLR1/2 agonist XS15) with nivolumab (PD‑1 inhibitor) and ipilimumab (CTLA‑4 inhibitor) to augment vaccine‑primed T‑cell responses; a re‑enrollment option may use nivolumab plus vaccine if prior CTLA‑4 toxicity.

ClinicalTrials.gov ID: NCT04248569

An Open-Label, Dose Escalation, Phase I/II Clinical Trial of ET140203 T Cells in Pediatric Subjects With Relapsed/Refractory Hepatoblastoma (HB), Hepatocellular Neoplasm-Not Otherwise Specified (HCN-NOS), or Hepatocellular Carcinoma (HCC)

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Pediatric and young adult patients (1–21 years) with relapsed/refractory, AFP-high (≥100 ng/mL), HLA-A2–positive hepatoblastoma, HCN-NOS, or HCC receive a single infusion of autologous ET140203 T cells after lymphodepletion. ET140203 (JWATM-203) is an engineered T-cell therapy using an ARTEMIS receptor with a TCR-mimic that targets AFP158–166/HLA-A*02:01 to selectively kill AFP+/HLA-A2+ liver cancer cells.

ClinicalTrials.gov ID: NCT04634357

First in Human Dose Escalation Study of AU409 in Patients With Advanced Primary Liver Cancers or Advanced Solid Tumor With Liver Predominant Metastatic Disease

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with advanced primary liver cancers (HCC or cholangiocarcinoma) or solid tumors with liver‑predominant metastases (≤2 extrahepatic sites), ECOG 0–1, receive oral AU409 in 28‑day cycles. AU409 is a first‑in‑class small‑molecule RNA transcription modulator designed to alter liver cancer transcription programs; key exclusions include untreated/symptomatic CNS metastases, significant cardiac risk, Child‑Pugh ≥B7 (for HCC), and strong CYP inducer/inhibitor use.

ClinicalTrials.gov ID: NCT05791448