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A Study of Inavolisib for Patients with Advanced Endometrial Cancer Who Have PIK3CA Gene Mutations

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at endometrial cancer that has advanced, come back, or spread to other parts of the body. The cancer must have a specific change in the genes called a PIK3CA mutation. A mutation is an alteration in the genetic material of cells that can affect how they behave. The treatment being tested is a medicine called inavolisib, which is also known by its code name GDC-0077. This medicine works by blocking a specific pathway in cancer cells that helps them grow. The study will also look at another gene called PTEN to see if it affects how well the treatment works. Patients in this study must have received treatment with platinum-based chemotherapy before, either with or without immunotherapy.

The main goal of this study is to find out how well inavolisib works in treating endometrial cancer that has the PIK3CA mutation. The researchers will measure this by looking at how many patients have their tumors shrink or disappear completely. The study will also look at other things such as how long patients live without their cancer getting worse, how long the response to treatment lasts, and whether the treatment works differently depending on which specific PIK3CA mutation a patient has or whether their PTEN gene is working normally. The safety of the medicine will also be carefully monitored throughout the study.

Patients will take inavolisib as a film-coated tablet by mouth. Before starting treatment, patients will need to provide a tissue sample from their cancer and blood samples for testing to confirm they have the PIK3CA mutation and to check the PTEN gene status. During the study, blood samples will be collected to track changes in the cancer. The treatment will continue as long as it is helping and not causing unacceptable side effects. Patients will be followed to see how their cancer responds to the treatment using imaging scans and other assessments.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and baseline assessments

    Your blood will be tested to check various health markers. This includes checking your blood cell counts, liver function (measured by tests called AST and ALT), kidney function (measured by creatinine clearance), blood sugar levels (including fasting blood glucose and HbA1c), and other blood components.

    Your physical condition will be assessed using a scale called ECOG performance status, which measures how the disease affects your daily living abilities. This should be done within 28 days before starting the trial.

    If you are of childbearing potential, a pregnancy test (urine or blood) will be performed within 24 hours before receiving the first dose of the study medication.

    A tumor tissue sample from your previous surgery or biopsy will be submitted for quality control analysis. This sample must contain adequate tumor material for testing.

    A blood sample will be collected before treatment begins. This will be used to detect tumor-related genetic changes in your blood.

    Your tumor tissue will be tested to confirm the presence of specific genetic changes in the PIK3CA gene and to determine the status of the PTEN gene. The results must show specific mutations to qualify for the trial.

    Your tumor characteristics will be documented, including mismatch repair status, hormone receptors (estrogen and progesterone receptors), and p53 status.

    Your disease will be measured according to RECIST 1.1 criteria, which is a standardized way to measure tumor size. You must have at least one measurable tumor that can be tracked during the trial.

  2. Step 2

    Treatment with inavolisib

    You will receive inavolisib, which is an oral medication in the form of a film-coated tablet.

    The medication is taken by mouth. Specific dosage, frequency, and duration details are not provided in the trial documentation.

    You must be able to swallow oral medications to participate in this trial.

    Treatment will continue as determined by your response to the medication and any side effects you may experience.

  3. Step 3

    Regular monitoring during treatment

    Your tumor size will be measured regularly using imaging scans. The medical team will assess whether your tumor has shrunk (partial response), disappeared completely (complete response), stayed the same, or grown.

    Blood tests will be performed throughout the treatment period to monitor your health and check for any side effects.

    Blood samples will be collected during therapy to track genetic changes related to the tumor (ctDNA testing). This helps monitor how the tumor is responding to treatment at a molecular level.

    Any side effects will be recorded and assessed according to a standardized system called CTCAE version 5.0, which categorizes side effects by severity.

    Your overall health status and ability to perform daily activities will be monitored regularly.

  4. Step 4

    Response assessment

    The medical team will determine whether the treatment is working by measuring changes in tumor size according to RECIST 1.1 criteria.

    The duration of any positive response to treatment will be recorded.

    Your disease status will be assessed at 6 months to determine if the cancer has progressed.

    The relationship between your specific genetic mutations (PIK3CA mutations and PTEN status) and your response to treatment will be analyzed.

  5. Step 5

    Long-term follow-up

    Your survival status will be tracked for at least one year after starting treatment.

    If you stop taking the medication, you may continue to be followed for assessment of long-term outcomes.

    If you are of childbearing potential, you must continue using highly effective contraception for at least 2 weeks after taking the final dose of inavolisib.

Who can join the trial?

18 criteria

  • You must sign an informed consent form before any study procedures begin
  • You must be expected to live for 16 weeks or longer
  • Your ability to perform daily activities must be good, rated as 0 or 1 on a scale called ECOG performance status, which measures how the disease affects your daily living abilities
  • Your tumor must be tested for certain markers including mismatch repair status (a measure of how cells repair DNA damage), hormone receptors (proteins that respond to estrogen and progesterone), and p53 status (a protein that helps control cell growth)
  • You must be able to swallow and take medications by mouth
  • Your blood tests must show adequate organ and bone marrow function, including having enough red blood cells (hemoglobin at least 9.0 g/dL without recent blood transfusions), white blood cells, normal liver function tests, normal kidney function, and normal blood clotting times
  • Your blood sugar levels must be controlled with fasting blood glucose (sugar level after not eating) below 140 mg/dL and HbA1c (a measure of average blood sugar over time) below 6.5%. If you have type 2 diabetes, you can participate if you are taking no more than one oral diabetes medication on a stable dose
  • If you are a woman who can become pregnant, you must use highly effective birth control during the study and for at least 2 weeks after the last dose of study medication, and have a negative pregnancy test before starting treatment
  • You must not be pregnant or breastfeeding
  • You must be willing and able to follow the study schedule, including visits, treatments, and laboratory tests
  • You must be female and at least 18 years old
  • You must have a confirmed diagnosis of advanced, recurrent, or metastatic endometrial cancer (cancer of the lining of the uterus that has spread or come back)
  • Your tumor must have a specific genetic change called a PIK3CA mutation, confirmed by laboratory testing
  • Test results showing your PIK3CA mutation and the status of another gene called PTEN must be available when you enroll
  • You must provide a tumor tissue sample from your original surgery or biopsy and a fresh blood sample before treatment starts
  • Your cancer must have worsened during or after treatment with platinum-based chemotherapy (a type of cancer treatment using platinum-containing drugs). If you received this chemotherapy after surgery, your cancer must have returned within 6 months of finishing treatment
  • You must have received no more than 4 previous treatments for your endometrial cancer. Hormone therapies and certain maintenance treatments are not counted in this limit
  • You must have at least one tumor that can be measured on imaging scans according to standard criteria called RECIST 1.1

Who cannot join the trial?

4 criteria

  • Men cannot participate in this study because it is only for female patients
  • Children and adolescents under 18 years of age cannot participate in this study
  • Patients who do not have a PIK3CA mutation, which is a specific change in a gene that can be found through laboratory testing, cannot participate
  • Patients whose endometrial cancer, which is cancer of the lining of the womb, is not advanced cannot participate
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Investigated drugs

Inavolisib is a medication being tested in this clinical trial for patients with advanced endometrial cancer who have specific genetic changes called PIK3CA mutations. This drug works by blocking certain proteins in cancer cells that help them grow and survive. The study aims to see how well this medication works in shrinking or controlling the growth of endometrial cancer tumors in patients with these specific genetic changes.

What is already known about the treatment

Inavolisib – Inavolisib is an experimental cancer medication currently being studied in phase II clinical trials for treating advanced endometrial cancer in patients who have specific genetic changes called PIK3CA mutations. This drug works by blocking a protein called PI3K-alpha, which is involved in helping cancer cells grow and survive, and when this protein is overactive due to mutations, it can drive tumor growth. The medication is being tested to see how well it can shrink tumors or stop them from growing in patients with this particular type of uterine cancer. It belongs to a class of drugs known as targeted therapy medications, specifically PI3K inhibitors, which are designed to attack cancer cells more precisely than traditional chemotherapy.

Investigated diseases

Endometrial Cancer – Endometrial cancer is a type of cancer that begins in the lining of the uterus, called the endometrium. This disease occurs when cells in the endometrium start to grow abnormally and uncontrollably, forming a tumor. As the cancer develops, it may invade deeper layers of the uterine wall and potentially spread to nearby tissues and organs. The disease often starts with changes in the endometrial cells that gradually become cancerous over time. In advanced stages, the cancer may spread beyond the uterus to other parts of the body through the lymphatic system or bloodstream. Some cases of endometrial cancer are associated with specific genetic mutations, including changes in genes such as PIK3CA and PTEN.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522981-61-00Protocol codeMITO END-4Estimated enrolment48 patientsSponsorIRCCS Istituto Nazionale Tumori Fondazione Pascale

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