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Study of Tulmimetostat (CPI-0209) for Patients with Advanced Solid Tumors and Lymphomas

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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 the effects of a new treatment called CPI-0209 in patients with advanced forms of cancer. The types of cancer being studied include various solid tumors and lymphomas. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas, while lymphomas are cancers that begin in the cells of the immune system. Some specific cancers included in this study are urothelial carcinoma, ovarian clear cell cancer, endometrial carcinoma, malignant pleural or peritoneal mesothelioma, and metastatic castration-resistant prostate cancer (mCRPC). The treatment being tested, CPI-0209, is taken orally in the form of a film-coated tablet and contains the active substance tulmimetostat.

The purpose of this study is to determine the best dose of CPI-0209 and to evaluate its effectiveness in treating these advanced cancers. The study is divided into two phases. In the first phase, researchers aim to find the maximum dose that patients can tolerate. In the second phase, the focus is on assessing how well CPI-0209 works in shrinking or controlling the tumors. Patients participating in the study will receive either CPI-0209 or a placebo, and their health will be monitored closely throughout the trial.

Participants in the study will undergo regular health assessments, including blood tests and imaging scans, to track the progress of their treatment. The study will help researchers understand the potential benefits and side effects of CPI-0209, contributing to the development of new treatment options for patients with these challenging types of cancer. The trial is expected to continue until 2025, providing valuable insights into the treatment of advanced solid tumors and lymphomas.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will begin participation in a clinical trial focused on the medication CPI-0209, which is administered in the form of a film-coated tablet for oral use.

    The trial is designed to evaluate the effects of CPI-0209 in patients with advanced solid tumors and lymphomas.

  2. Step 2

    Phase 1: Dose Escalation

    The primary objective of Phase 1 is to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CPI-0209.

    Patients will receive CPI-0209 as a monotherapy, meaning it is the only treatment being administered during this phase.

  3. Step 3

    Phase 2: Antitumor Activity Evaluation

    In Phase 2, the focus shifts to evaluating the antitumor activity of CPI-0209 in patients with selected advanced solid tumors and lymphomas.

    The effectiveness of the treatment will be assessed based on the response of the tumors to the medication.

  4. Step 4

    Medication Administration

    CPI-0209 is administered as a film-coated tablet taken orally. The specific dosage and frequency will be determined based on the findings from Phase 1.

    The duration of administration will continue throughout the trial phases, with adjustments made as necessary based on patient response and tolerance.

  5. Step 5

    Monitoring and Assessments

    Throughout the trial, patients will undergo regular monitoring to assess the safety and effectiveness of CPI-0209.

    This includes tracking any adverse events, changes in laboratory values, and overall response to the treatment.

  6. Step 6

    Trial Completion

    The estimated end date for the trial is July 18, 2025. Patients will continue to receive treatment and monitoring until the trial concludes or until they meet criteria for discontinuation.

    Final assessments will be conducted to evaluate the overall outcomes of the treatment with CPI-0209.

Who can join the trial?

12 criteria

  • Must be an adult, aged 18 years or older.
  • Both male and female patients, and their partners, who can have children, must agree to use at least one highly effective birth control method while on the study and for a certain period after the last dose of the study drug.
  • Must sign a consent form approved by an ethics committee before any study-related procedures are done.
  • Must have advanced or metastatic tumors (solid tumors or lymphoma) that have returned or worsened after standard treatment, or have a disease with no standard effective treatment.
  • Must have a life expectancy of at least 12 weeks.
  • Must provide a tumor sample for testing at the start of the study.
  • Must be willing to provide blood and tumor samples for testing specific markers related to the study.
  • Must have recovered from any side effects of previous treatments to a mild level, unless the side effects are not significant or are stable with supportive care.
  • Must have a good performance status, meaning they can carry out daily activities without significant limitations.
  • Must have adequate bone marrow function, which means having enough healthy blood cells.
  • Must have adequate kidney function, which means the kidneys are working well enough to clear waste from the blood.
  • Must have adequate liver function, which means the liver is working well enough to process substances in the body.

Who cannot join the trial?

15 criteria

  • Patients who have not fully recovered from previous treatments or surgeries.
  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had another cancer within the last 5 years, except for certain skin cancers or in situ cancers, which are very early-stage cancers.
  • Patients who are currently participating in another clinical trial.
  • Patients with known allergies to the study medication or similar drugs.
  • Patients with active infections that require treatment.
  • Patients with a history of certain heart conditions.
  • Patients with uncontrolled high blood pressure.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have received a live vaccine within 30 days before the start of the study.
  • Patients with certain blood disorders.
  • Patients with a history of autoimmune diseases, which are conditions where the immune system attacks the body.
  • Patients with a history of organ transplants.
  • Patients with a history of brain or spinal cord conditions.
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Investigated drugs

CPI-0209 is an investigational medication being studied for its potential to treat advanced solid tumors and lymphomas. In this clinical trial, researchers are working to determine the highest dose of CPI-0209 that patients can tolerate without severe side effects. They are also evaluating how effective CPI-0209 is in reducing or controlling the growth of these tumors. The study is divided into two phases: the first phase focuses on finding the right dose, while the second phase assesses the medication's ability to fight cancer.

What is already known about the treatment

CPI-0209 – CPI-0209 is administered orally and is currently being studied in clinical trials for its effectiveness in treating advanced solid tumors and lymphomas. It is in the early phases of clinical research, with ongoing studies to determine the optimal dosage and assess its antitumor activity. The main therapeutic indications include various advanced cancers such as urothelial carcinoma, ovarian clear cell cancer, endometrial carcinoma, and lymphomas, among others. CPI-0209 works by inhibiting specific proteins involved in cancer cell growth and survival, aiming to slow down or stop the progression of the disease. It is classified as an investigational cancer therapy, focusing on its potential to target and disrupt cancer cell mechanisms.

Investigated diseases

  • Urothelial Carcinoma

    This is a type of cancer that occurs in the urinary system, primarily affecting the bladder. It begins in the urothelial cells that line the inside of the bladder and can spread to nearby tissues and organs. As it progresses, it may invade deeper layers of the bladder wall and potentially metastasize to other parts of the body.

  • Ovarian Clear Cell Cancer

    This is a rare form of ovarian cancer characterized by the presence of clear cells in the tumor. It typically presents as a solid mass in the ovaries and can be aggressive, often diagnosed at an advanced stage. The cancer may spread to other parts of the body, including the abdominal cavity and lymph nodes.

  • Endometrial Carcinoma

    This cancer originates in the lining of the uterus, known as the endometrium. It often presents with abnormal uterine bleeding and can invade the uterine wall and spread to other pelvic organs. If not detected early, it may metastasize to distant sites such as the lungs or liver.

  • Peripheral T-cell Lymphoma

    This is a group of aggressive lymphomas that originate from mature T-cells. It can present with symptoms such as swollen lymph nodes, fever, and weight loss. The disease can spread rapidly to other lymph nodes and organs, including the liver and bone marrow.

  • Germinal Center B-cell Diffuse Large B-cell Lymphoma (GCB-DLBCL)

    This is a subtype of non-Hodgkin lymphoma that arises from B-cells in the germinal center of lymph nodes. It is characterized by rapidly growing tumors that can occur in various parts of the body. The disease can spread to other lymph nodes and organs, leading to systemic symptoms.

  • Malignant Pleural Mesothelioma

    This is a rare cancer that develops in the lining of the lungs, known as the pleura. It is often associated with asbestos exposure and can cause symptoms such as chest pain and shortness of breath. The cancer can invade nearby tissues and organs, and may spread to distant sites.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-508002-20-00Protocol codeCDZR123A02101Estimated enrolment275 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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