RecruitingPhase 1Phase 2NCT06811116

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

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


Sponsor

National Cancer Institute (NCI)

Enrollment

92 participants

Start Date

Nov 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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 carcinoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (called SAPHIRE) is testing whether adding a drug called sapanisertib to the standard treatment cabozantinib improves outcomes for people with advanced liver cancer (hepatocellular carcinoma or HCC) that has a specific genetic mutation in a protein called beta-catenin. **You may be eligible if...** - You have confirmed liver cancer (HCC) that cannot be cured with surgery or local treatments - Your tumor has a beta-catenin (CTNNB1) gene mutation, confirmed by genetic testing - You have already received at least one prior systemic (whole-body) cancer treatment - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - Your tumor does not have a beta-catenin mutation - You have not yet received any prior cancer treatment - Your liver or other organ function is too impaired - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood collection

DRUGCabozantinib S-malate

Given PO

PROCEDUREImaging Procedure

Undergo imaging scans

DRUGSapanisertib

Given orally (PO)


Locations(4)

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Oregon Health and Science University

Portland, Oregon, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT06811116


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