RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing Cabozantinib S-malate for Advanced Hepatocellular Carcinoma

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.

Official registry: https://clinicaltrials.gov/study/NCT06811116 · National Cancer Institute (NCI) · enrollment listed as 92

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Biospecimen Collection, Cabozantinib S-malate, or Imaging Procedure. The registry lists allocation as randomized. 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.

They plan to enroll about 92 people at 4 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.

Official title (unrewritten)

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

Interventions: Biospecimen Collection, Cabozantinib S-malate, Imaging Procedure, Sapanisertib

Primary outcome (registry wording): Dose-limiting toxicities and incidence of adverse events

Who it is for (from inclusion criteria)

Ages 18 Years to any
Patients must have histologically or cytologically confirmed HCC, not amenable to curative treatment approach
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
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

Who the registry excludes

Patients who have not recovered from side effects 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

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

4 listed

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California (recruiting)
UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California (recruiting)
Oregon Health and Science University — Portland, Oregon (recruiting)
UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania (recruiting)

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FAQ about this NCT record

Is NCT06811116 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06811116?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06811116?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary