Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial

This phase I/II trial studies the side effects and best dose of sapanisertib when given together with cabozantinib, and to see how well they work in treating patients with liver cancer that has spread from where it first started to other places in the body (metastatic) and contains a mutation (change) in the β-catenin gene. Sapanisertib and cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving sapanisertib and cabozantinib together may work better than giving cabozantinib alone in treating β-catenin-mutated metastatic hepatocellular carc

Trial Details

NCT ID
NCT06811116
Phase
PHASE1 / PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Hepatocellular Carcinoma (HCC) Liver Cancer
Interventions
  • Biospecimen Collection
  • Cabozantinib S-malate
  • Imaging Procedure
  • Sapanisertib
Locations (sample)
  • Irvine, California, United States|33.66946,-117.82311
  • Orange, California, United States|33.78779,-117.85311
  • Portland, Oregon, United States|45.52345,-122.67621
  • Pittsburgh, Pennsylvania, United States|40.44062,-79.99589

Key Eligibility Criteria

  • Patients must have histologically or cytologically confirmed HCC, not amenable to curative treatment approach
  • For Phase 2, patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longe…
  • For phase 2, patients must have a β-catenin mutation, based on next generation eequencing (NGS) testing through Clinical Laboratory Improvement Ame…
  • Patients must have received at least one prior line of systemic therapy in the metastatic setting, including a prior immune checkpoint inhibitor th…

For full eligibility, visit ClinicalTrials.gov.

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