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Phase 1b Study of CC-90010 with Temozolomide in Adults with Newly Diagnosed Glioblastoma After Surgery

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

The study focuses on adults who have been newly diagnosed with glioblastoma after having part or all of the tumor surgically removed. The usual care for this type of brain cancer includes an oral chemotherapy drug called temozolomide, and in many cases it is given together with radiation therapy. The trial adds an experimental oral medication, identified as CC-90010, to the standard treatment plan.

The purpose of the trial is to learn whether the combination of the experimental drug with the usual chemotherapy, with or without radiation, is safe and to determine the most appropriate dose. Participants will take the standard chemotherapy pills and the study tablets each day, may receive radiation therapy according to the usual schedule, and will be followed with regular clinic visits for several months.

During the study, doctors will watch for any side effects and will use routine imaging scans and blood tests to see how the tumor responds and how the new drug behaves in the body. The information gathered will help decide the best dose to use in future research.

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

    Baseline Evaluation

    You will undergo a series of medical examinations, laboratory tests, and imaging studies to confirm that you meet the study requirements for newly diagnosed glioblastoma.

    These assessments establish a reference point for future safety and effectiveness evaluations.

  2. Step 2

    Start of Concomitant Therapy

    If radiation therapy is included in your treatment plan, you will begin taking CC-90010 together with temozolomide while receiving radiation.

    Both medications are taken by mouth; the exact dose of each capsule or tablet will be prescribed by the study team based on the dose‑finding schedule.

    Radiation therapy is delivered to the brain over several weeks to target remaining tumor cells.

  3. Step 3

    Completion of Radiation Therapy

    After the radiation course ends, you will stop the radiation sessions but continue the oral medications.

    The study will verify that you have tolerated the combined treatment before moving to the next phase.

  4. Step 4

    Adjuvant Therapy Phase

    You will continue to take CC-90010 and temozolomide as oral medication without radiation.

    The treatment cycles repeat for a period defined by the study protocol; each cycle consists of daily dosing for a set number of days followed by a rest period, as instructed by the study team.

    Capsules of temozolomide are available in strengths of 5 mg, 20 mg, 100 mg, 140 mg, and 250 mg; the appropriate strength will be selected to achieve the prescribed total dose.

  5. Step 5

    Safety Monitoring Visits

    During both the concomitant and adjuvant phases, you will attend regular clinic visits for blood tests, imaging, and physical examinations.

    These visits are used to record any adverse events and to assess the severity of side effects using the NCI CTCAE version 5.0 grading system.

  6. Step 6

    End‑of‑Study Follow‑Up

    After the planned treatment period, you will have final assessments to evaluate tumor status and overall health.

    The study will continue to collect information on survival and disease progression for a defined follow‑up period.

Who can join the trial?

17 criteria

  • Be 18 years of age or older, male or female.
  • Have a life expectancy of at least 6 months (the doctor expects you to live at least six more months).
  • Have an ECOG performance status of 0 or 1, which means you are fully active or able to do light work but not bedridden.
  • Have laboratory test results (blood work, etc.) that meet the study’s required ranges.
  • Have a newly diagnosed, confirmed WHO Grade IV glioblastoma (a type of brain tumor) and have had the tumor removed partially or completely by surgery.
  • Have recovered from any surgery‑related problems such as infections or other complications.
  • If receiving the treatment at the same time as radiation, your tumor surgery must have been performed within the past 8 weeks before the first study dose.
  • If receiving the treatment after radiation, you must have finished standard or shortened radiation therapy combined with the chemotherapy drug temozolomide (TMZ) and have a recent MRI scan showing the tumor is stable before the first study dose.
  • Any side effects from the previous radiation‑plus‑TMZ treatment must have improved to mild (grade 1) or less, except for certain lab values.
  • You must not have experienced severe (grade 4) blood‑related toxicity from the prior radiation‑plus‑TMZ treatment.
  • You must have received at least 80 % of the planned radiation and/or TMZ doses during the usual 42‑ to 49‑day treatment period.
  • You must allow the study team to use a stored sample of your tumor tissue for genetic testing.
  • Women who could become pregnant must either stay completely abstinent or use a highly effective birth‑control method plus a barrier method (such as a condom) from the time you sign the consent form until at least 46 days after the last dose of CC‑90010 and 180 days after the last dose of TMZ. You must also have two negative pregnancy tests before starting the study and agree to ongoing pregnancy testing.
  • Men must stay abstinent or use a condom with a pregnant partner or a woman who could become pregnant, from the time you sign the consent form until at least 106 days after the last dose of CC‑90010 and 180 days after the last dose of TMZ. Men must also agree not to donate semen during the study and for 106 days after stopping CC‑90010 (or 180 days after the last TMZ dose, whichever is longer).
  • Women must agree not to donate eggs (ova) while on the study and for 46 days after the last CC‑90010 dose (or 180 days after the last TMZ dose, whichever is longer).
  • Understand the study, agree to take part, and sign an informed consent form before any study procedures begin.
  • Be willing and able to attend all scheduled study visits and follow the study requirements.

Who cannot join the trial?

17 criteria

  • Prior chemotherapy or other anti‑tumor treatment for glioblastoma, except surgery (and required TMZ+RT for the adjuvant group).
  • Active chronic hepatitis B (HBV) or hepatitis C (HCV) infection (people with only vaccine‑induced antibodies or on preventive medication are allowed).
  • Ongoing treatment with therapeutic doses of blood‑thinning medicines (anticoagulants), except low‑dose low molecular weight heparin used only for catheter care.
  • Having another active cancer that needs systemic treatment, except certain non‑melanoma skin cancer, fully removed early‑stage cervical carcinoma in situ, low‑risk prostate cancer (with PSA ≤ 0.1 ng/mL) or cancers treated curatively more than three years ago.
  • History of bleeding problems, or any bleed that was moderate or worse (CTCAE Grade 2) or coughing up more than a teaspoon of blood (hemoptysis) within four weeks before the first dose.
  • Past episodes of a specific eye condition called non‑arteritic anterior ischemic optic neuropathy (NAION); also, caution if you have retinitis pigmentosa (a retinal disease).
  • Any serious medical, laboratory, or psychiatric problem that would make participation unsafe or difficult.
  • Any condition that would make it hard to understand the study results.
  • Poor bone‑marrow reserve, such as needing regular hematopoietic support (blood‑cell transfusions).
  • Ongoing moderate or severe diarrhea from a malabsorptive syndrome, or other major gastrointestinal (GI) disorder that could affect drug absorption.
  • Active or uncontrolled stomach or duodenal ulcers, especially if there is a risk of perforation or bleeding.
  • Recent bleeding inside the brain seen on MRI or CT scan (CNS hemorrhage).
  • Need for increasing doses of corticosteroids to control cerebral edema within 14 days before the first dose.
  • Known active inflammation of the pancreas (pancreatitis, acute or chronic).
  • Impaired cardiac function or serious heart disease as defined in the study protocol.
  • Being pregnant or breastfeeding (nursing).
  • Having HIV infection.
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Investigated drugs

  • Temozolomide

    is an oral chemotherapy medicine that is taken in capsule form. In this study it is used as the standard treatment for newly diagnosed glioblastoma. The drug works by damaging the DNA of cancer cells, which helps stop them from growing and dividing. Participants receive temozolomide after surgery, and it may be given together with the experimental drug or with radiation, depending on the part of the trial they are in.

  • CC-90010

    is an experimental oral medication being tested for the first time in people with glioblastoma. It is a tablet that is taken by mouth. The study is looking at how safe it is and what dose can be given when it is combined with temozolomide, with or without radiation therapy. Researchers hope that CC-90010 may work together with temozolomide to improve treatment outcomes.

  • Radiation therapy

    is a treatment that uses high‑energy X‑rays (or similar radiation) aimed at the brain tumor area. In this trial, radiation is given after surgery and at the same time as temozolomide and CC-90010 for some participants. The purpose of radiation is to kill remaining cancer cells and shrink the tumor, helping to improve the effectiveness of the medicines.

What is already known about the treatment

  • Temozolomide

    This medication is taken by mouth in the form of hard capsules. It is an approved chemotherapy drug that is widely used to treat newly diagnosed glioblastoma, a type of brain cancer. Temozolomide works by adding a small chemical group to the DNA of cancer cells, which damages their DNA and stops them from dividing. It belongs to the class of alkylating agents, which are drugs that interfere with DNA replication.

  • CC‑90010

    This drug is taken by mouth as a tablet and is currently being studied in early‑phase clinical trials for use in glioblastoma. It is an experimental agent that blocks a protein called LSD1, which helps cancer cells control the activity of many genes needed for their growth. By inhibiting this protein, CC‑90010 aims to slow or stop tumor growth. It is classified as an epigenetic modulator, a type of medication that changes how genes are turned on or off.

Investigated diseases

Glioblastoma, WHO grade IV - Glioblastoma is an aggressive brain tumor that arises from glial cells. It typically grows quickly and can invade nearby brain tissue. Symptoms often develop as the tumor enlarges, such as headaches, seizures, or changes in personality. After surgical removal, any remaining tumor cells can continue to multiply. The disease may spread within the brain and cause further neurological decline. Over time, the tumor can become larger and affect more functions.
Trial detailsLast updated 20 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-511171-15-00Protocol codeCC-90010-GBM-002Estimated enrolment216 patientsSponsorCelgene Corp.

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