Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Study of INCB099280 for Patients With Advanced Cutaneous Squamous Cell Carcinoma Not Suitable for Surgery or Radiotherapy

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 type of skin cancer known as advanced cutaneous squamous cell carcinoma (cSCC). The trial is evaluating a new treatment called INCB099280, which is taken as a film-coated tablet. Participants in the study will include those who have not received prior immunotherapy and have either not been treated before or have a recurring form of this cancer that cannot be effectively treated with surgery or radiation.

The purpose of the study is to assess the safety and initial effectiveness of INCB099280 at different doses. Participants will take the medication orally, and the study will monitor their response to the treatment over a period of time. The trial will involve regular check-ups and assessments to ensure the safety and well-being of the participants while gathering data on how the cancer responds to the treatment.

Throughout the study, participants will be closely observed for any side effects or changes in their condition. The trial aims to provide valuable information on whether INCB099280 can be a safe and effective treatment option for those with advanced cSCC. The study is expected to continue until mid-2025, with participants receiving the treatment for a maximum of 24 weeks.

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 participant will be required to sign a consent form, indicating their understanding and willingness to participate.

    Eligibility is confirmed based on age, diagnosis of advanced cutaneous squamous cell carcinoma (cSCC), and other criteria such as measurable disease and life expectancy.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted, which includes a review of medical history, physical examination, and baseline imaging or photography to document the disease.

    A tumor sample may be required for analysis, either from previous procedures or a new biopsy.

  3. Step 3

    Treatment phase

    Participants will receive the study medication, INCB099280, in the form of film-coated tablets.

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

    The duration of this phase will depend on individual response and tolerance to the medication.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring will occur to assess the safety and effectiveness of the treatment. This includes physical exams, vital signs, ECGs, and laboratory tests.

    Participants will be evaluated for any side effects or adverse events, which may lead to adjustments in dosage or discontinuation of the medication.

  5. Step 5

    Evaluation of response

    The response to treatment will be evaluated using imaging or photography to measure changes in the disease.

    The primary goal is to determine the objective response, which includes complete or partial reduction of the disease.

  6. Step 6

    End of study participation

    Participation in the study will conclude based on the study's timeline or if the participant chooses to withdraw.

    Final assessments will be conducted to gather data on the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

9 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 have a confirmed diagnosis of **cSCC** (cutaneous squamous cell carcinoma). Tumors on the lip are eligible if they started on the skin part of the lip.
  • Must have **cSCC** that is either untreated or has come back, and cannot be cured with surgery or radiation, as decided by a doctor.
  • Must have a disease that can be measured using imaging tests or photographs, with at least one tumor that is 10 mm or larger.
  • Must have an **ECOG performance status** of 0 or 1, which means the person is fully active or has some symptoms but can still do light work.
  • Must have a tumor sample available or be willing to have a biopsy to get a sample for analysis. The sample should be from a recent biopsy or surgery, not older than 1 year (or 6 months for slides).
  • Must have a life expectancy of more than 3 months, according to the study doctor.
  • Must agree to avoid pregnancy or fathering children during the study and for a certain period after the last dose of the study drug. Men must take precautions to avoid fathering children and not donate sperm. Women of childbearing potential must have a negative pregnancy test and take precautions to avoid pregnancy, and not donate eggs during the study and for a specified time after.

Who cannot join the trial?

7 criteria

  • Patients who have already received **immunotherapy**. Immunotherapy is a type of treatment that helps your immune system fight cancer.
  • Patients who have had surgery or **radiotherapy** that could cure their cancer. Radiotherapy is a treatment that uses high-energy rays to kill cancer cells.
  • Patients who have other serious health conditions that might make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or take the study medication as required.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who are participating in another clinical trial at the same time.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruitingNot recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

INCB099280 is an investigational medication being studied for its potential to treat advanced cutaneous squamous cell carcinoma (cSCC). The trial aims to evaluate how safe and tolerable this medication is for patients, as well as its preliminary effectiveness in managing the condition.

What is already known about the treatment

INCB099280 – This medication is administered orally in tablet form, taken twice daily. It is currently under investigation in clinical trials for its safety, tolerability, and preliminary effectiveness in treating advanced cutaneous squamous cell carcinoma (cSCC) in patients who have not previously received immunotherapy and whose condition cannot be managed with surgery or radiotherapy. The drug is being studied for its potential to inhibit specific molecular pathways involved in cancer cell growth and survival. It is classified as an investigational agent in the field of oncology, focusing on targeted cancer therapies.

Investigated diseases

Cutaneous Squamous Cell Carcinoma (cSCC) – This is a type of skin cancer that arises from the squamous cells, which are flat cells located in the outer part of the epidermis. It often develops in areas of the skin that have been exposed to the sun, such as the face, ears, neck, and hands. The disease can start as a rough, scaly patch or a sore that does not heal. Over time, it may grow larger and can become invasive, spreading to nearby tissues or other parts of the body. In advanced stages, cSCC may not be suitable for surgical removal or radiation therapy. The progression of cSCC can vary, with some cases remaining localized while others may become more aggressive.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502476-23-00Protocol codeINCB 99280-212Estimated enrolment241 patientsSponsorIncyte Corp.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.