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Study of TAK-280, Tocilizumab, and Siltuximab for Patients with Advanced or Metastatic Cancer

Verified siteRegistered drugNo 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 a new treatment for patients with unresectable locally advanced or metastatic cancer. The treatment being tested is called TAK-280, which is a solution given through an intravenous infusion, meaning it is administered directly into the bloodstream. The study aims to understand how safe and tolerable TAK-280 is for patients, and to find the most suitable dose for future use.

During the trial, participants will receive TAK-280 and will be closely monitored by healthcare professionals. The study will also involve other medications like Tocilizumab and Siltuximab, which are also given through intravenous infusion. Some participants may receive a placebo instead of the active medication. The trial will help researchers learn more about how TAK-280 affects the body and how it might help in treating cancer.

Participants will visit the study site regularly for treatment and check-ups. These visits will allow the research team to monitor the participants' health and any side effects they might experience. The study is expected to last for several months, and the information gathered will contribute to understanding the potential benefits and risks of TAK-280 for treating advanced cancer.

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, participation begins with an initial assessment to confirm eligibility based on specific criteria, such as age and cancer diagnosis.

    The study focuses on patients with unresectable locally advanced or metastatic cancer.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of TAK-280, a medication given through an intravenous infusion.

    The dosage and frequency of TAK-280 are determined during the study, with the aim of identifying the safest and most effective dose.

  3. Step 3

    Monitoring and assessments

    Regular monitoring is conducted to assess the body's response to TAK-280. This includes measuring the concentration of the drug in the blood at various time points.

    Assessments occur on specific days, such as Days 1, 2, 3, 8, 15, and 22, and continue throughout the treatment period, which may last up to 14 months.

  4. Step 4

    Evaluation of treatment effects

    The study evaluates the treatment's effects by tracking any adverse events and determining the maximum tolerated dose.

    The primary goal is to ensure the safety and tolerability of TAK-280.

  5. Step 5

    Long-term follow-up

    Participants are followed for up to approximately 37 months to monitor overall survival and progression-free survival.

    The study also measures the duration of response and disease control rate.

Who can join the trial?

4 criteria

  • Must be **18 years or older** or meet the local legal age of adulthood.
  • Must have a type of cancer that is **unresectable** (cannot be removed by surgery), **locally advanced** (spread to nearby areas), or **metastatic** (spread to other parts of the body).
  • Must have a **performance status** of 1 or less according to the Eastern Cooperative Oncology Group (ECOG) scale, which measures how well a person can perform daily activities.
  • Must have a **measurable disease** according to specific guidelines, except for certain prostate cancer cases with bone spread. Areas previously treated with radiation or other local treatments should not be used to measure unless treated at least 6 months ago or if there is clear evidence of disease progression.

Who cannot join the trial?

4 criteria

  • Patients with a type of cancer that cannot be removed by surgery and has spread to other parts of the body.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specific group required for the study.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

TAK-280 is an experimental medication being studied for its potential use in treating patients with advanced or metastatic cancer that cannot be surgically removed. The trial aims to understand how safe and tolerable this medication is for patients, as well as to identify any side effects that limit its dosage. The study will help determine the most effective dose that can be used in future research.

What is already known about the treatment

TAK-280 – TAK-280 is administered intravenously, meaning it is given directly into a vein. It is currently in the early stages of clinical trials, specifically a Phase 1/2 study, to evaluate its safety and effectiveness in treating patients with unresectable locally advanced or metastatic cancer. The main therapeutic indication for TAK-280 is to target and treat these advanced cancer types. At the molecular level, TAK-280 works by interfering with specific pathways that cancer cells use to grow and multiply, although the exact mechanism is still under investigation. It is classified pharmacologically as an investigational anti-cancer agent.

Investigated diseases

Unresectable Locally Advanced or Metastatic Cancer – This type of cancer refers to tumors that have grown too large or are located in a position that makes surgical removal impossible. The term "locally advanced" indicates that the cancer has spread beyond its original site but has not yet reached distant organs. "Metastatic" means the cancer has spread to other parts of the body, forming new tumors. As the disease progresses, it can affect various bodily functions depending on the organs involved. Symptoms may vary widely based on the cancer's location and the extent of its spread. The progression of this disease often involves increasing symptoms and complications related to the affected areas.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-504012-16-00Protocol codeTAK-280-1501Estimated enrolment149 patientsSponsorTakeda Development Center Americas Inc.

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