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Testing Sapanisertib with Cabozantinib for Metastatic Liver Cancer

This study is testing if adding sapanisertib to the usual chemotherapy, cabozantinib, works better for people with liver cancer that has spread (metastatic hepatocellular carcinoma) and has a specific change in their β-catenin gene. Both sapanisertib and cabozantinib are thought to stop cancer cells from growing by blocking certain enzymes. The study aims to find the best dose of sapanisertib when given with cabozantinib and to see how well this combination works compared to cabozantinib alone. You may be able to join if you have advanced liver cancer that cannot be cured by other treatments and have this specific gene change. The study plans to enroll 92 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 92 participants to compare the combination of sapanisertib and cabozantinib against cabozantinib alone.
What's involved
Participants will undergo blood collection, imaging scans, and take cabozantinib and sapanisertib orally. The duration of participation is from registration until disease progression or death, assessed for up to 2 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from registration until disease progression or death due to any cause, assessed for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06811116

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
National Cancer Institute (NCI)
~92 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCabozantinib S-malateImaging ProcedureSapanisertib

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting toxicities and incidence of adverse events
Measured over From registration to disease progression or death due to any cause, assessed up to 2 years
+1 more outcome measured

Conditions

Advanced Hepatocellular Carcinoma
Metastatic Hepatocellular Carcinoma
Stage III Hepatocellular Carcinoma AJCC v8
Stage IV Hepatocellular Carcinoma AJCC v8

Explore related trials

Hepatocellular CarcinomaCTNNB1 Gene

NCT06811116

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Oregon Health and Science University

    Portland, Oregonstudy coordinator listed

    Recruiting

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, Californiastudy coordinator listed

    Recruiting

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, Californiastudy coordinator listed

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Anwaar Saeed · PRINCIPAL_INVESTIGATOR · UPMC Hillman Cancer Center LAO

Who to contact

Site Public Contact
[email protected]
877-827-8839
Email the study team

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Eligibility criteria

Inclusion

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 (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥ 10 mm (≥ 1 cm) with CT scan, MRI, or calipers by clinical exam
For phase 2, patients must have a β-catenin mutation, based on next generation sequencing (NGS) testing through Clinical Laboratory Improvement Amendments (CLIA)-certified commercially available standard of care assay
Patients must have received at least one prior line of systemic therapy in the metastatic setting, including a prior immune checkpoint inhibitor therapy unless not eligible. For the phase 2 portion, patients must have received at least one and no more than two prior lines of systemic therapy in the metastatic setting, including a prior immune checkpoint inhibitor therapy unless not eligible
Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of sapanisertib in combination with cabozantinib in patients \<18 years of age, children are excluded from this study
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%)
Child Pugh score of A
Absolute neutrophil count ≥ 1,000/mcL
Platelets ≥ 60,000/mcL
Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) ≤ 5 × institutional ULN
Glomerular filtration rate (eGFR) ≥ 40 mL/min/1.73 m\^2
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
For the phase 2 portion, availability of archival tumor tissue at the time of patient enrollment for banking for molecular profiling studies
The effects of sapanisertib and cabozantinib on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and after completion of drug administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Both men and women treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation, and for the following duration after completion of sapanisertib and cabozantinib administration:
90 days and 120 days after last dose of sapanisertib for women of childbearing potential and men respectively,
5 months and 7 months after last dose of cabozantinib for women of childbearing potential and men respectively
Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants

Exclusion

Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia
Patients who are receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to sapanisertib and cabozantinib
Use of strong CYP3A4-inhibiting agents due to drug-drug interaction with cabozantinib
Prior exposure to cabozantinib
Patients who are unable to swallow oral medications such as capsules and tablets and patients with gastrointestinal conditions that may affect the absorption of oral medications
Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous
Pregnant women are excluded from this study because sapanisertib and cabozantinib have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sapanisertib and cabozantinib, breastfeeding should be discontinued if the mother is treated with sapanisertib and cabozantinib

What this trial measures

  • Dose-limiting toxicities and incidence of adverse eventsFrom registration to disease progression or death due to any cause, assessed up to 2 years

    Dose limiting toxicities and adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be tabulated for each dose level.

  • Progression free survival (PFS)From registration to disease progression or death due to any cause, assessed up to 2 years

    Treatment response will be assessed based on Response Evaluation Criteria in Solid Tumors version 1.1. PFS will be estimated by the Kaplan-Meier method, along with 95% confidence regions. Median PFS will also be calculated along with its 95% confidence intervals (CI).