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Study of ETX-19477 for Patients with Advanced Solid Tumors After Standard Treatment

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What is this trial about?

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

This clinical trial is focused on studying a new treatment for patients with advanced solid cancers that have continued to grow despite standard treatments. The treatment being tested is a medication called ETX-19477, which is taken in the form of a capsule. This medication is a type of drug known as a PARG inhibitor, which is designed to interfere with certain processes in cancer cells, potentially slowing their growth or causing them to die.

The purpose of the study is to find the best dose of ETX-19477 that patients can tolerate and to understand how safe it is. The study will also look at how well the drug works against the cancer. The study is divided into two phases. In the first phase, researchers will determine the safest dose and observe any side effects. In the second phase, they will assess how effective the drug is in treating the cancer. Participants will take the medication by mouth and will be monitored regularly to check their health and the cancer's response to the treatment.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their cancer. The study aims to provide valuable information about the potential benefits and risks of using ETX-19477 for treating advanced solid cancers. This research could lead to new treatment options for patients with these types of cancers in the future.

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 visit

    Upon joining the study, you will have an initial visit. During this visit, you will be asked to provide a sample of your tumor, either from a previous biopsy or a new one if necessary. This is to help understand your specific condition better.

    You will also undergo a series of tests to ensure you meet the study's health requirements. These tests will check your blood, liver, and kidney functions, among other things.

  2. Step 2

    Start of treatment

    Once all initial assessments are complete, you will begin taking the study medication, ETX-19477. This medication is in the form of a capsule and is taken orally.

    The dosage and frequency will be determined by the study team based on your specific needs and the phase of the trial you are in.

  3. Step 3

    Regular monitoring

    Throughout the study, you will have regular visits to monitor your health and the effects of the medication. These visits will include physical exams, blood tests, and possibly imaging tests to track the progress of your condition.

    The study team will also monitor for any side effects or adverse reactions to the medication.

  4. Step 4

    Adjustments and feedback

    Based on the results of your regular monitoring, the study team may adjust your medication dosage or frequency. This is to ensure the best possible outcome and to manage any side effects.

    You will be asked to provide feedback on how you are feeling and any changes you notice in your condition.

  5. Step 5

    End of treatment

    At the end of the treatment period, you will have a final set of assessments to evaluate the overall impact of the medication on your condition.

    You will be asked to continue providing feedback on your health and any long-term effects you may experience.

Who can join the trial?

19 criteria

  • Must be a male or female aged 18 years or older.
  • Must be able to understand and voluntarily sign an informed consent document before any study-related assessments or procedures.
  • Must have a confirmed diagnosis of advanced solid cancer, which means the cancer is incurable, has come back, cannot be removed by surgery, or has spread to other parts of the body. This does not include primary brain tumors.
  • The cancer must have worsened after the most recent treatment or the patient must not be able to tolerate the treatment. Patients should have received standard therapy that is known to help, unless it is not suitable, cannot be tolerated, or the patient chooses not to have it. The reason for declining treatment must be clearly documented and approved by the study's medical monitor.
  • Must have a type of tumor that fits the study's requirements:
    • For Phase 1: Any solid tumor, except primary brain tumors, that has worsened after the most recent treatment or cannot be tolerated.
    • For Phase 2:
      • Epithelial ovarian cancer: No more than 4 previous treatments for advanced or spreading disease, including at least one platinum-based chemotherapy.
      • ER+ Breast cancer: No more than 4 previous treatments for advanced or spreading disease (no limit on previous hormonal therapies).
      • Castration-Resistant Prostate Cancer: No more than 4 previous treatments. Previous taxane chemotherapy is allowed. Ongoing hormone therapy to lower testosterone is required, with testosterone levels below 50 ng/dL within 28 days before the first dose of the study drug.
      • Other advanced tumors: No more than 4 previous treatments.
      • Must have measurable disease according to specific criteria. Patients with breast, prostate, or ovarian cancer with non-measurable but evaluable disease are also eligible.
      • Must have an ECOG performance status of 0-1, which means the patient is fully active or has some symptoms but does not need bed rest during the day.
      • Must have a life expectancy of at least 3 months.
      • Must be willing to provide a tumor sample before treatment, either from a previous sample or a new biopsy. If a sample is not available or a biopsy is not safe or feasible, enrollment may be allowed with approval.
      • All side effects from previous cancer treatments must have improved to a mild level or returned to the state before treatment, except for hair loss or mild nerve damage.
      • Must have adequate blood, kidney, and liver function, as determined by specific medical tests.
      • Must not have taken any experimental drugs within 3 weeks or 5 half-lives (whichever is shorter, with a minimum of 2 weeks) before the first dose of the study drug.
      • Female patients who can have children must agree to use highly effective birth control or abstain from sex during the study and for 90 days after stopping the study treatment. Male patients must be surgically sterile or abstinent, or both the male and their female partners must agree to use highly effective birth control with an additional barrier method (such as a condom) during the study and for 90 days after stopping the study treatment.
      • Must be able to swallow oral medication.
      • Must be willing and able to follow the study visit schedule and other study requirements.

Who cannot join the trial?

10 criteria

  • Patients who have not received standard treatment for their advanced solid tumors.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to understand or comply with the study procedures.
  • Patients who are pregnant or breastfeeding.
  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent major surgery or injury.
  • Patients with a history of allergic reactions to similar medications.
  • Patients with active infections that require treatment.
  • Patients with certain heart conditions that are not well controlled.
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Investigated drugs

ETX-19477 is a new medication being tested in this clinical trial. It is designed to help treat patients with advanced solid tumors, which are a type of cancer. The main goal of this study is to find out how much of this medication can be given safely to patients and to see how well it works against the cancer. In the first part of the trial, researchers are trying to determine the safest dose that patients can tolerate. In the second part, they are looking at how effective the medication is in shrinking or controlling the tumors. This medication is still being studied, so it is not yet available outside of the clinical trial setting.

What is already known about the treatment

ETX-19477 – ETX-19477 is administered orally and is currently being studied in clinical trials for its potential use in treating patients with advanced solid tumors that have not responded to standard treatments. This medication is in the early stages of research, specifically in Phase 1 and Phase 2 trials, where its safety, tolerability, and effectiveness are being evaluated. ETX-19477 is designed to inhibit a specific enzyme called PARG, which plays a role in repairing damaged DNA in cancer cells, potentially leading to their death. It falls under the pharmacological classification of enzyme inhibitors, specifically targeting cancer cells to prevent their growth and spread.

Investigated diseases

Advanced Solid Malignancies – Advanced solid malignancies refer to a group of cancers that form solid tumors in various organs and have progressed beyond initial stages. These tumors can arise in tissues such as the breast, lung, prostate, or colon. As the disease advances, the cancer cells grow uncontrollably and may spread to other parts of the body, a process known as metastasis. The progression of these malignancies often involves the tumor increasing in size and potentially invading nearby tissues. Over time, the cancer can affect the function of the organ where it originated and other organs it spreads to. The disease's progression is typically monitored through imaging and other assessments to evaluate tumor growth and spread.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-518326-32-00Estimated enrolment126 patientsSponsor858 Therapeutics Inc.

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