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Study of AMG 193 alone and combined with docetaxel for treatment of advanced MTAP-null solid tumors in adult patients

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What is this trial about?

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

This study focuses on advanced MTAP-null solid tumors, which are cancers characterized by the absence of a specific gene called MTAP. The research evaluates a new medication called AMG 193, which will be tested both alone and in combination with another cancer drug called docetaxel. AMG 193 is taken as an oral tablet and belongs to a class of drugs known as PRMT5 inhibitors, which work by blocking certain proteins involved in cancer growth.

The purpose of this research is to understand how safe and effective AMG 193 is when used to treat patients with advanced solid tumors that lack the MTAP gene. The study is divided into multiple parts, with initial phases focusing on finding the right dose and checking how the body processes the medication, while later phases examine how well the treatment works in fighting the cancer.

During the study, participants will receive either AMG 193 alone or in combination with docetaxel. The treatment involves taking tablets by mouth. Throughout the study, doctors will monitor various aspects of the participants' health and how their cancer responds to the treatment. They will track important measures such as tumor size changes and how long patients live without their disease getting worse.

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 eligibility confirmation

    Your medical team will verify if you meet the key requirements, including:

    - Being at least 18 years old

    - Having a confirmed advanced tumor that cannot be fully treated with surgery or radiation

    - Having specific genetic markers (MTAP-null) in your tumor

    - Being able to take and keep down oral medications

    - Having a tumor that can be measured using standard imaging techniques

  2. Step 2

    Health status verification

    Medical tests will confirm that you have:

    - Healthy heart function

    - Normal blood cell counts

    - Proper kidney function

    - Adequate liver function

    - Good lung function

  3. Step 3

    Treatment phase - Part 1

    You will receive AMG 193 tablets to take by mouth

    Your health will be closely monitored for any side effects

    Regular assessments will measure how the medication moves through your body

    Imaging scans will track any changes in your tumor

  4. Step 4

    Treatment phase - Part 2

    You will receive a combination of:

    - AMG 193 tablets taken by mouth

    - Docetaxel (a standard cancer medication)

    Your response to both medications will be carefully monitored

  5. Step 5

    Treatment phase - Part 3

    This phase focuses on measuring how well the treatment works

    Regular imaging will track any changes in your tumor

    Your overall health and survival will be monitored

    The study may continue until March 2029

Who can join the trial?

11 criteria

  • Must be 18 years or older
  • Must have confirmed advanced solid tumor that cannot be cured with surgery or radiation therapy
  • Must have evidence of specific genetic changes showing loss of CDKN2A or MTAP genes, confirmed by special laboratory tests
  • Must have tumor that can be measured using standard imaging criteria (RECIST v1.1)
  • Must be able to swallow and keep down oral medications
  • Must be willing to keep daily records of medication use
  • Must have good bone marrow function (ability to produce blood cells)
  • Must have good kidney function
  • Must have good liver function
  • Must have good heart function
  • Must have good lung function

Who cannot join the trial?

14 criteria

  • History of allergic reactions or severe sensitivity to AMG 193 or similar medications
  • Presence of active brain metastases (cancer that has spread to the brain) that are not stable or require ongoing treatment
  • Significant heart conditions including:
    • Uncontrolled high blood pressure
    • Recent heart attack (within 6 months)
    • Unstable heart rhythm problems
    • Active infections requiring treatment with medications
    • Other ongoing cancer treatments (chemotherapy, immunotherapy, or radiation) within 4 weeks before starting this study
    • Major surgery within 4 weeks before starting the study
    • Liver disease that significantly affects liver function
    • Kidney problems requiring dialysis
    • Pregnancy or breastfeeding
    • Unable to swallow oral medications
    • Any condition that, in the opinion of the study doctor, would make participation unsafe
    • Participation in another clinical trial within 4 weeks before starting this study
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Investigated drugs

  • AMG 193

    is an investigational medication being studied for the treatment of advanced solid tumors that have a specific genetic characteristic called MTAP-null. This medication is being tested both as a standalone treatment and in combination with other therapy.

  • Docetaxel

    is a chemotherapy medication that is already approved and commonly used to treat various types of cancer. It works by interfering with cell division, which helps to stop cancer cells from growing and spreading. In this trial, it is being studied in combination with AMG 193.

What is already known about the treatment

  • AMG 193

    An investigational drug being studied in clinical trials for the treatment of advanced MTAP-null solid tumors. It is administered as a targeted therapy, though the specific form of administration is not detailed in the available data. The drug is currently being evaluated in Phase 1/1b/2 clinical trials to assess its safety, tolerability, pharmacokinetics, and effectiveness, both as a standalone treatment and in combination with docetaxel. The medication is specifically designed for patients with metastatic or locally advanced MTAP-null solid tumors, representing a targeted approach in oncology treatment.

  • Docetaxel

    A well-established chemotherapy medication administered intravenously for the treatment of various types of cancer. It belongs to the taxane family of drugs and works by disrupting the normal function of microtubules, preventing cancer cells from dividing and multiplying. In this clinical trial, it is being studied in combination with AMG 193 for treating patients with advanced MTAP-null solid tumors, potentially offering a new combination therapy approach in cancer treatment.

Investigated diseases

MTAP-null solid tumors - A condition characterized by the development of solid cancerous masses that lack a specific enzyme called MTAP (Methylthioadenosine Phosphorylase). These tumors can form in various parts of the body and are marked by uncontrolled cell growth. The absence of the MTAP enzyme distinguishes these tumors from other types of cancer and affects how the cancer cells process certain metabolic compounds. These tumors can progress from localized (confined to one area) to advanced stages, where they may spread to nearby tissues. In advanced cases, the tumors can become metastatic, meaning they spread to different parts of the body from their original location.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-504363-17-00Protocol code20210023Estimated enrolment654 patientsSponsorAmgen Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).