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Study on the Safety and Effects of Tolinapant in Patients with Advanced Solid Tumors and Lymphomas

Verified siteInvestigationalNo placebo
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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 medication called Tolinapant, also known by its code name ASTX660. The study is aimed at people with advanced forms of cancer, specifically solid tumors and lymphomas. These are types of cancers that have either spread to other parts of the body or cannot be removed through surgery. The specific types of cancer being studied include head and neck cancer, diffuse large B-cell lymphoma, peripheral T-cell lymphoma, cutaneous T-cell lymphoma, and cervical cancer, among others.

The purpose of the study is to evaluate the safety and effectiveness of Tolinapant in treating these advanced cancers. Participants in the study will receive the medication in the form of a capsule taken by mouth. The study will be conducted in phases, with the first phase already completed. The second phase will focus on assessing how well the medication works in reducing the size of tumors or slowing their growth. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Tolinapant.

Throughout the study, participants will be monitored for any side effects and changes in their condition. The study aims to determine the best dose of Tolinapant and to gather information on how the body processes the medication. This information will help researchers understand the potential benefits and risks of using Tolinapant as a treatment for advanced cancers. The study is expected to continue until the end of 2025.

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

    Joining the study

    Upon joining the study, the patient will be informed about the trial's purpose, procedures, and potential risks. Written consent is required before any study-specific procedures are performed.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of advanced solid tumors or lymphomas that are metastatic or cannot be surgically removed.

    The patient must have measurable disease according to specific criteria and acceptable organ function as evidenced by laboratory tests.

  3. Step 3

    Treatment administration

    The patient will receive the study medication, Tolinapant, in the form of oral capsules. The dosage and frequency will be determined based on the phase of the study and the patient's specific condition.

    The treatment aims to assess the safety and preliminary effectiveness of the medication in treating certain types of cancer.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, the patient will undergo regular monitoring to assess the medication's effects and any side effects. This includes measuring the response rate of the tumor to the treatment.

    The study will also monitor the patient's overall health and any changes in the condition of the disease.

  5. Step 5

    Completion of the study

    The study is expected to continue until December 31, 2025. Upon completion, the patient's response to the treatment and overall survival will be evaluated.

    The patient will be informed of the study's findings and any potential next steps in their treatment plan.

Who can join the trial?

10 criteria

  • Must be able to understand and follow the study procedures, understand the risks, and provide written consent before any study-specific actions are taken.
  • Must be 18 years of age or older.
  • Must have advanced solid tumors or lymphoma that cannot be removed by surgery or has spread to other parts of the body, and for which no standard treatments are available.
  • For certain groups in the study, must have a specific type of T-cell lymphoma confirmed by a pathology report.
  • For certain groups, must show evidence of disease progression and have received at least two previous treatments.
  • Must have measurable disease according to specific criteria for their type of cancer.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, which indicates the level of daily functioning.
  • Must have acceptable organ function, shown by specific laboratory tests, including liver enzymes, bilirubin, neutrophil count, platelet count, and kidney function.
  • Women who can become pregnant must not be pregnant or breastfeeding and must have a negative pregnancy test before starting the study. Both women and men must agree to use two effective methods of birth control during the study and for at least three months after treatment ends.
  • After a certain amendment, participants must be benefiting from the study treatment, in the opinion of the study doctor, to continue participating.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer that are not included in the study.
  • Patients who have not recovered from previous cancer treatments.
  • Patients with serious heart problems.
  • Patients with uncontrolled infections.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had another cancer within the last 3 years, except for certain skin cancers or in situ cervical cancer, which is a very early stage of cervical cancer.
  • Patients with known allergies to the study drug or similar drugs.
  • Patients who have received another investigational drug within the last 4 weeks.
  • Patients with certain serious medical conditions that could interfere with the study.
  • Patients who are unable to follow the study procedures.
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Investigated drugs

ASTX660 is a medication being studied for its safety and effectiveness in treating advanced solid tumors and lymphomas. The trial aims to determine the best dose and dosing schedule for this medication. The study also looks at how well the medication works in reducing the size of tumors in certain types of cancer.

What is already known about the treatment

ASTX660 – This medication is administered orally and is currently being studied in clinical trials for its safety and effectiveness in treating advanced solid tumors and lymphomas. It is in the early stages of research, with ongoing studies to determine its potential benefits and optimal dosing. ASTX660 is primarily being investigated for its use in cases such as recurrent or metastatic head and neck squamous cell carcinoma, relapsed or refractory diffuse large B-cell lymphoma, and other similar conditions. The drug works by inhibiting specific proteins that help cancer cells survive, thereby promoting cancer cell death. It is classified as a small molecule inhibitor in pharmacology.

Investigated diseases

  • Head and Neck Squamous Cell Carcinoma

    This is a type of cancer that begins in the squamous cells lining the moist surfaces inside the head and neck. It often starts in areas such as the mouth, throat, or nose. The disease can progress by spreading to nearby tissues and lymph nodes. Over time, it may become recurrent or metastatic, meaning it returns after treatment or spreads to other parts of the body.

  • Diffuse Large B-Cell Lymphoma

    This is a common type of non-Hodgkin lymphoma that affects B-lymphocytes, a type of white blood cell. It typically presents as a rapidly growing mass, often in the lymph nodes, spleen, liver, or other organs. The disease can be aggressive, with symptoms developing quickly. It is characterized by its potential to relapse or become refractory, meaning it does not respond to treatment.

  • Peripheral T-Cell Lymphoma

    This is a group of rare and aggressive lymphomas that originate from mature T-cells. It can occur in various parts of the body, including lymph nodes, skin, and other organs. The disease often progresses rapidly and may become refractory or relapse after initial treatment. Symptoms can include swollen lymph nodes, fever, and weight loss.

  • Cutaneous T-Cell Lymphoma

    This is a rare type of non-Hodgkin lymphoma that primarily affects the skin. It begins in T-cells, which are part of the immune system, and causes skin lesions that can be itchy and painful. The disease can progress slowly over many years, but in some cases, it may become more aggressive. It is characterized by its potential to relapse or become refractory.

  • Cervical Carcinoma

    This is a type of cancer that occurs in the cells of the cervix, the lower part of the uterus that connects to the vagina. It often develops slowly over time, starting with precancerous changes in the cervical cells. If not detected and treated early, it can progress to invasive cancer. The disease may become unresponsive or relapse after standard therapy.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-516679-33-00Protocol codeASTX660-01Estimated enrolment150 patientsSponsorTaiho Oncology Inc.

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