Clinical Trials for Liver Cancer

A Phase I/II Trial of Sapanisertib in Combination With Cabozantinib in β-catenin-mutated Hepatocellular Carcinoma (SAPHIRE)

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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.

HealthScout AI summary: Adults with advanced/metastatic hepatocellular carcinoma, enriched for β‑catenin (CTNNB1)–mutated disease (Phase II requires CLIA-confirmed mutation, Child-Pugh A, ECOG 0–2, prior ICI), randomized to cabozantinib alone vs cabozantinib plus sapanisertib (TAK‑228), an oral ATP-competitive mTORC1/2 inhibitor. Allows controlled HBV/HCV and treated/stable brain mets; excludes prior cabozantinib and strong CYP3A4 inhibitors.

ClinicalTrials.gov ID: NCT06811116

Phase I Dose-Escalating Study of Combining Intravenous Tirapazamine and Transarterial Embolization (TAE) in Liver Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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.

HealthScout AI summary: Adults with well-differentiated, liver-dominant metastatic neuroendocrine tumors (ECOG 0–1) and documented intrahepatic progression receive intra-arterial tirapazamine immediately followed by conventional TAE (Lipiodol/Gelfoam). Tirapazamine is a hypoxia-activated prodrug that generates DNA-damaging radicals and functions as a tumor-selective topoisomerase II poison under low oxygen, aiming to potentiate embolization-induced hypoxia.

ClinicalTrials.gov ID: NCT02174549

A Phase 1-2 Study of ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

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.

HealthScout AI summary: Adults with advanced, unresectable HCC (ECOG 0–1, Child-Pugh A) after at least one prior systemic therapy receive nivolumab plus ABX196, an intramuscular synthetic α-galactosylceramide analog that activates iNKT cells via CD1d to augment antitumor immunity. Excludes main portal vein/IVC/cardiac invasion, significant recent variceal bleeding, active autoimmune disease requiring treatment, prior transplant, and significant decompensation; controlled HBV allowed.

ClinicalTrials.gov ID: NCT03897543

A Phase Ib/II, Dose Escalation and Dose Expansion Study of Valemetostat Tosylate (DS-3201b) With Atezolizumab and Bevacizumab in Advanced Hepatocellular Carcinoma (HCC)

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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.

HealthScout AI summary: Previously untreated adults with unresectable/advanced HCC (Child-Pugh A, BCLC B not eligible for liver-directed therapy or C, ECOG 0–1) receive valemetostat (oral dual EZH1/EZH2 inhibitor) combined with atezolizumab and bevacizumab on 21-day cycles. Excludes high bleeding risk (e.g., untreated/high-risk varices), active autoimmune disease requiring systemic therapy, uncontrolled HBV/HCV, and prior EZH inhibitor exposure.

ClinicalTrials.gov ID: NCT06294548

REVERT- Liver Cancer: A Phase 1b/2 Multicenter, Open-label Study to Evaluate the Safety and Efficacy of TTI-101 as Monotherapy and in Combination in Participants With Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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.

HealthScout AI summary: Adults with unresectable, locally advanced or metastatic HCC (Child-Pugh A–B7, ECOG 0–1) receive the oral STAT3 inhibitor TTI-101 as monotherapy after prior systemic therapy, or in combination with pembrolizumab after PD-1/PD-L1 progression, or with atezolizumab plus bevacizumab in the first-line setting. The study evaluates safety and preliminary efficacy, with standard bevacizumab eligibility and exclusion of patients with contraindications to immunotherapy.

ClinicalTrials.gov ID: NCT05440708

A Phase II Trial of Hepatic Ablation of Metastases to Modulate and Enhance Immunotherapy Response (HAMMER) in NSCLC

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: This trial targets adults with stage IV NSCLC involving liver metastases, excluding those with EGFR or BRAF mutations and prior liver radiation, to evaluate the impact of adding liver stereotactic ablative radiotherapy (L-SABR) to a standard regimen of anti-PD-(L)1 based immunotherapy and optional platinum-based chemotherapy.

ClinicalTrials.gov ID: NCT05657873

A Phase 1 Study of the Safety and Efficacy of CRX100 as Monotherapy and in Combination With Pembrolizumab in Advanced Solid Malignancies

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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.

HealthScout AI summary: This trial targets adult patients with advanced solid malignancies and evaluates the safety and efficacy of CRX100, an investigational immunotherapy combining autologous T cells and oncolytic vaccinia virus, as monotherapy and in combination with Pembrolizumab.

ClinicalTrials.gov ID: NCT04282044

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303/BNT323 in Patients With Advanced/Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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.

HealthScout AI summary: Adults with advanced or metastatic solid tumors expressing HER2 (including HER2-low), who are refractory or intolerant to standard therapies, receive the investigational HER2-targeted antibody-drug conjugate DB-1303/BNT323 (anti-HER2 IgG1 linked to a DNA topoisomerase I inhibitor) IV every 3 weeks; select cohorts also examine combinations with pertuzumab or CYP inhibitors for drug-drug interaction assessment.

ClinicalTrials.gov ID: NCT05150691

Safety and Efficacy of Brodalumab in the Treatment of Immune-Related Adverse Events: A Pilot Study

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors who developed IL-17–mediated immune-related adverse events after immunotherapy and require systemic steroids, testing brodalumab (an IL-17 receptor A inhibitor) as a potential steroid-sparing treatment for irAEs. Patients receive subcutaneous brodalumab alongside a planned steroid taper.

ClinicalTrials.gov ID: NCT06673329

A Phase I Dose Escalation / Dose Expansion Study of NBTXR3 Activated by Radiotherapy for Patients with Advanced Cancers Treated with an Anti-PD-1 Therapy

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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.

HealthScout AI summary: This trial enrolls patients with advanced, injectable metastatic or recurrent head and neck squamous cell carcinoma, NSCLC, melanoma, hepatocellular, renal, urothelial, cervical, or triple-negative breast cancer—regardless of anti-PD-1 status—to receive a single intratumoral injection of NBTXR3 (a hafnium oxide nanoparticle radioenhancer) activated by SABR, followed by anti-PD-1 therapy with nivolumab or pembrolizumab.

ClinicalTrials.gov ID: NCT03589339