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Study of INCB099280 for Patients with Advanced Solid Tumors Who Have Not Received Immunotherapy

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 new treatment called INCB099280 on certain types of cancer known as solid tumors. These tumors are advanced or have come back after treatment, and the patients have not previously received a type of treatment called immunotherapy. The purpose of the study is to understand how safe and tolerable the treatment is, and to see how well it works in managing these tumors.

Participants in the study will take INCB099280 in the form of a film-coated tablet. The study will test different doses of the medication, specifically 400 mg, 600 mg, and 800 mg, taken twice a day. The treatment period can last up to 24 weeks. During the study, participants will be monitored for any side effects and changes in their condition. Some participants may receive a placebo, which is a tablet that looks like the treatment but does not contain the active medication.

The study aims to gather information on how the treatment affects the tumors, including whether it can shrink them or stop them from growing. It will also look at how long any positive effects last and how the treatment impacts the overall health and survival of the participants. The results will help determine if INCB099280 could be a useful treatment option for people with these types of cancer 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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    Eligibility criteria include being 18 years or older, having a life expectancy of more than 3 months, and being immunotherapy naive.

  2. Step 2

    Treatment initiation

    The treatment involves taking the medication INCB099280, which is provided in the form of film-coated tablets.

    The medication is taken orally, with dosages of 400 mg, 600 mg, or 800 mg twice a day (BID).

  3. Step 3

    Ongoing monitoring

    Regular monitoring is conducted to assess the safety and tolerability of the medication. This includes physical examinations, vital signs checks, and ECGs.

    Clinical laboratory samples are analyzed to monitor for any treatment-emergent adverse events (TEAEs).

  4. Step 4

    Response evaluation

    The primary goal is to evaluate the objective response, which includes assessing the best overall response of confirmed complete response (CR) or partial response (PR).

    Secondary evaluations include disease control, duration of response (DOR), time to response (TTR), progression-free survival (PFS), and overall survival (OS).

  5. Step 5

    Study completion

    The study is estimated to conclude by June 29, 2024. Participants will continue to be monitored until the end of the study period.

    Final assessments will be conducted to determine the overall efficacy and safety of the treatment.

Who can join the trial?

7 criteria

  • Must be able to understand and willing to sign a written consent form for the study.
  • Must be 18 years or older at the time of signing the consent form.
  • Must not have received immunotherapy before.
  • Must have a measurable disease according to specific guidelines (RECIST v1.1).
  • Must have a performance score of 0 or 1 on the ECOG scale, which measures daily living abilities (a score of up to 2 is allowed for those with UC).
  • Must have a life expectancy of more than 3 months.
  • Must be willing to avoid becoming pregnant or fathering children during the study.

Who cannot join the trial?

4 criteria

  • Patients who have already received immunotherapy for their cancer. Immunotherapy is a type of treatment that helps the body's immune system fight cancer.
  • Patients who have certain medical conditions that the study is not designed to treat.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population that the study is not designed to include.
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Investigated drugs

INCB099280 is an investigational medication being studied for its potential to treat certain types of advanced solid tumors. The trial aims to assess how safe and tolerable this medication is for patients who have not previously been treated with immune checkpoint inhibitors. Researchers are also looking at how effective the medication might be in managing these tumors.

What is already known about the treatment

INCB099280 – This medication is administered orally in tablet form, taken twice daily. It is currently being studied in clinical trials for its safety, tolerability, and preliminary effectiveness in treating advanced solid tumors, particularly in patients who have not previously received immune checkpoint inhibitors. The main therapeutic indication is for recurrent or advanced/metastatic solid tumors. At the molecular level, INCB099280 works by modulating the immune system to enhance the body's ability to fight cancer cells. It is classified pharmacologically as an immune checkpoint inhibitor.

Investigated diseases

Recurrent or advanced/metastatic solid tumors – These are cancers that originate in solid organs or tissues and have either returned after treatment or spread to other parts of the body. The progression of these tumors can vary widely depending on the type and location of the cancer. In advanced stages, the cancer cells grow uncontrollably and may invade nearby tissues or organs. Metastatic tumors have spread from the original site to distant parts of the body, often through the bloodstream or lymphatic system. These tumors can affect various bodily functions depending on where they spread. The disease's progression is influenced by factors such as the tumor's growth rate and the body's response to the cancer cells.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502716-37-00Protocol codeINCB 99280-211Estimated enrolment328 patientsSponsorIncyte Corp.

sourced from the EU Clinical Trials Register and site verification

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