Clinical Trials for Liver Cancer

AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma

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 biopsy-proven advanced hepatocellular carcinoma (or LI-RADS 5) who are not candidates for curative/locoregional therapy or have progressed after it (ECOG 0–2; Child-Pugh A or B7; measurable disease) receive dose-escalated triple therapy with sorafenib (oral multikinase/VEGFR pathway inhibitor) plus sonidegib (oral Hedgehog pathway SMO inhibitor) plus irinotecan (IV topoisomerase I inhibitor). This single-arm study determines the maximum tolerated dose over 32 days with AI/phenotypic and ctDNA-informed individualized dosing; UGT1A1*28 homozygotes are excluded.

ClinicalTrials.gov ID: NCT05669339

A Phase 1b/2 Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of Melphalan Percutaneous Hepatic Perfusion Therapy (HEPZATO KIT™) With Nivolumab and Relatlimab (Opdualag) in Patients With Metastatic Melanoma and Liver Metastasis

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: For adults with unresectable/metastatic melanoma with biopsy-confirmed liver metastasis who are systemic-treatment naïve in the metastatic setting (prior adjuvant anti–PD-1 and/or BRAF/MEK allowed if >6 months), this study combines liver-directed melphalan percutaneous hepatic perfusion via the HEPZATO KIT (temporary hepatic vascular isolation with extracorporeal filtration to limit systemic exposure) with fixed-dose Opdualag (nivolumab PD-1 blockade plus relatlimab LAG-3 blockade to enhance T-cell activation). It evaluates safety and preliminary systemic and hepatic antitumor activity.

ClinicalTrials.gov ID: NCT07281924

A Phase 1b Study of 177Lu-PSMA-617 Combined With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer

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: Enrolls men with progressive mCRPC with PSMA-avid extrahepatic disease and liver metastases amenable to local therapy after prior androgen receptor pathway inhibitor therapy. Patients receive up to 6 cycles of 177Lu-PSMA-617, a PSMA-targeted beta-emitting radioligand, combined with liver-directed transarterial chemoembolization and/or ablation to address hepatic metastases including potentially PSMA-negative lesions.

ClinicalTrials.gov ID: NCT07145177

A Randomized, Multicenter, Double-Blind, Parallel-Controlled, Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma

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 18–65 with previously untreated advanced/unresectable hepatocellular carcinoma, Child-Pugh A, ECOG 0, and measurable disease are randomized to HLX13, an investigational ipilimumab biosimilar anti-CTLA-4 antibody, versus US-sourced ipilimumab, each combined with nivolumab anti-PD-1. The study primarily assesses pharmacokinetic biosimilarity, with safety, immunogenicity, and preliminary response endpoints.

ClinicalTrials.gov ID: NCT07176650

A Phase I/II Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)

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.

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: This trial involves adults with unresectable or metastatic advanced solid tumors who have progressed on prior treatments or are candidates for pembrolizumab, combining pembrolizumab, which targets the PD-1 receptor to enhance immune response, with a personalized neoantigen peptide vaccine designed to stimulate an individualized immune attack against tumor-associated proteins.

ClinicalTrials.gov ID: NCT05269381

A Phase 1b/2a Multi-Center, Dose Escalation and Reference Regimen-Controlled, Multi-Cohort Study to Determine the Safety and Efficacy of Oral 7HP349 (Alintegimod) in Combination with Ipilimumab Followed by Nivolumab Monotherapy in Patients with Locally Advanced or Metastatic Cancers Following One or More Prior Therapies

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: This trial involves patients with advanced or metastatic solid tumors, such as melanoma and non-small cell lung cancer, who have had prior therapies, evaluating the safety and efficacy of Alintegimod, an integrin-targeting agent, combined with ipilimumab and nivolumab.

ClinicalTrials.gov ID: NCT06362369

A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B2033, Alone or in Combination With Tislelizumab, in Participants With Selected Advanced or Metastatic Solid Tumors

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: This trial enrolls adults with advanced or metastatic GPC3-expressing solid tumors (including hepatocellular carcinoma, AFP-producing gastric cancer, extragonadal yolk sac tumors, non-dysgerminomas, or GPC3-positive squamous NSCLC) who have ECOG 0-1. Patients will receive the investigational bispecific antibody BGB-B2033 (targeting GPC3 and 4-1BB) alone or combined with the anti-PD-1 antibody tislelizumab.

ClinicalTrials.gov ID: NCT06427941

A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors

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: This trial enrolls adults with unresectable, locally advanced or metastatic solid tumors—including a wide range such as head and neck, lung, bladder, prostate, breast, colorectal, and others—who have progressed on or are intolerant to standard therapies. Patients receive MGC026, a B7-H3-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor (exatecan), with cohorts in both dose escalation and expansion phases.

ClinicalTrials.gov ID: NCT06242470

A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors

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: Eligible patients are adults with metastatic solid tumors (ECOG 0-1, measurable disease, adequate organ function) who will receive MDX2001, a tetraspecific antibody that engages T cells via CD3/CD28 and targets TROP2 and c-MET on tumor cells. The trial excludes individuals with major cardiac disease, active brain metastases, uncontrolled infections, or unresolved toxicities.

ClinicalTrials.gov ID: NCT06239194

A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV 324 in Adults With Hepatocellular Cancer or Squamous Cell Non-Small Cell Lung Cancer

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: This trial enrolls adults with advanced or metastatic hepatocellular carcinoma or squamous-cell non-small cell lung cancer who have progressed after at least one prior systemic therapy (including immune checkpoint inhibitors and platinum-based chemotherapy for NSCLC), and randomizes patients to receive intravenous ABBV-324 (investigational agent with undisclosed mechanism) or lenvatinib. Both dose escalation and optimization phases are included, with ABBV-324 given as monotherapy.

ClinicalTrials.gov ID: NCT06858813