Actively Recruiting
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
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
92
Participants Needed
4
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed hepatocellular carcinoma not eligible for curative treatment
- Measurable disease with lesions at least 2 cm by chest x-ray or 1 cm by CT, MRI, or clinical exam (phase 2 only)
- Beta-catenin mutation confirmed by next generation sequencing (phase 2 only)
- Received at least one prior systemic therapy for metastatic disease, including prior immune checkpoint inhibitor unless not eligible
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Child Pugh score of A
- Absolute neutrophil count at least 1,000/mcL
- Platelet count at least 30,000/mcL
- Total bilirubin no more than 1.5 times the upper limit of normal
- AST and ALT levels no more than 5 times the upper limit of normal
- Estimated glomerular filtration rate (eGFR) at least 40 mL/min/1.73 m2
- HIV-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months
- Patients with chronic hepatitis B must have undetectable viral load on suppressive therapy if needed
- Hepatitis C patients must be cured or have undetectable viral load if currently treated
- Patients with treated brain metastases without progression on follow-up imaging
- Patients with new or progressive brain metastases if immediate CNS treatment not required or likely in first cycle
- Patients with prior or concurrent malignancies not interfering with study assessments
- Cardiac function classified as New York Heart Association Class II or better
- Availability of archival tumor tissue for molecular profiling (phase 2 only)
- Agreement to use adequate contraception during and after study drug administration
- Ability and willingness to provide informed consent
You will not qualify if you...
- Unresolved side effects greater than grade 1 from previous cancer treatments (except hair loss)
- Use of other investigational drugs
- Allergic reactions to drugs similar to sapanisertib or cabozantinib
- Use of strong CYP3A4 inhibitors due to drug interactions
- Prior treatment with cabozantinib
- Inability to swallow oral medications or gastrointestinal conditions affecting drug absorption
- Uncontrolled illnesses or conditions making participation unsafe
- Pregnant or breastfeeding women due to potential risks to fetus or infant
AI-Screening
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Trial Site Locations
Total: 4 locations
1
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
2
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
3
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
4
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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