Sapanisertib + Cabozantinib for Liver Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: CYP3A4 inhibitors

Disqualifiers: Pregnancy, Allergies, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

92 Participants Needed

Trial Summary

What is the purpose of this 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 carcinoma.

Research Team

Anwaar Saeed

Principal Investigator

UPMC Hillman Cancer Center LAO

Eligibility Criteria

This trial is for adults with metastatic liver cancer that has a β-catenin gene mutation. They must have tried at least one systemic therapy, be in good physical condition (ECOG ≤ 2), and have proper liver function (Child Pugh score A). Patients should not join if they've had more than two systemic treatments or are too sick to participate.

Inclusion Criteria

My cancer has a β-catenin mutation.

My white blood cell count is healthy.

My bilirubin levels are within normal range.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase I

Dose-escalation study of sapanisertib and cabozantinib to establish the recommended phase 2 dose

28 days per cycle, multiple cycles

Daily oral administration, regular blood collection and imaging scans

Treatment Phase II

Randomized study comparing sapanisertib and cabozantinib combination versus cabozantinib alone

28 days per cycle, multiple cycles

Daily oral administration, regular blood collection and imaging scans

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 3 months for 2 years

Treatment Details

Interventions

• Cabozantinib
• Sapanisertib

Trial Overview The SAPHIRE Trial is testing the combination of Sapanisertib and Cabozantinib versus Cabozantinib alone in treating metastatic liver cancer with a specific gene change. It aims to find the best dose and see if this combo is more effective.

Participant Groups

Group I: Arm I (Sapanisertib + cabozantinib) Experimental Treatment 4 Interventions

Patients receive sapanisertib PO QD and cabozantinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood collection and imaging scans throughout the study.

Group II: Arm II (Cabozantinib) Active Control 3 Interventions

Patients receive cabozantinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood collection imaging scans throughout the study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+