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Study on the Safety and Effectiveness of BLU-222 Alone and with Drug Combination for Patients with Advanced Solid Tumors, Including Breast and Ovarian Cancer

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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 advanced solid tumors, which include various types of cancers such as breast cancer, ovarian cancer, endometrial cancer, and gastric cancer. The study will explore the effects of a new treatment called BLU-222, which is being tested both on its own and in combination with other medications. These medications include carboplatin, ribociclib, and fulvestrant. The purpose of the study is to evaluate the safety and effectiveness of BLU-222 in treating these cancers.

Participants in the study will receive BLU-222 either as a single treatment or alongside the other mentioned medications. The study will be conducted in two phases. In the first phase, researchers will determine the best dose of BLU-222 and assess its safety. In the second phase, the focus will be on understanding how well BLU-222 works in treating the cancers. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatment.

The study will involve regular check-ups and monitoring to ensure the safety of the participants and to gather information on how the treatment affects the cancer. This will help researchers understand the potential benefits and any side effects of BLU-222. The trial is expected to continue until 2026, providing valuable insights into the treatment of advanced solid tumors.

The research process

The trial runs in 4 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 related to the type of cancer and previous treatments.

  2. Step 2

    Phase 1 treatment

    The first phase involves determining the appropriate dosage of BLU-222, either alone or in combination with other medications. This phase focuses on evaluating safety and how the body processes the medication.

    Medications include BLU-222 (oral capsule), ribociclib (oral tablet), fulvestrant (injection), and carboplatin (IV infusion).

  3. Step 3

    Phase 2 treatment

    In the second phase, the focus shifts to assessing the effectiveness of BLU-222 at the determined dose. This phase also evaluates the safety of the medication when used alone or with other treatments.

    The same medications from phase 1 are used, with the dosage adjusted based on findings from the first phase.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, regular monitoring of health status, including vital signs and laboratory tests, is conducted to ensure safety and track the response to treatment.

    Follow-up assessments are scheduled to evaluate the long-term effects and overall response to the treatment.

Who can join the trial?

7 criteria

  • The patient must have an advanced solid tumor that has gotten worse after receiving standard treatments.
  • If the patient has HR+ HER2-negative breast cancer, it must have worsened after treatment with a specific type of medicine called a CDK4/6 inhibitor.
  • For patients with endometrial or gastric cancer, the cancer must have worsened after at least two previous treatments, including one with a medicine called platinum therapy.
  • If the patient has ovarian cancer, it must be platinum refractory or platinum resistant, meaning it did not respond well to platinum-based treatments.
  • The patient must have CCNE1 amplified tumors that have worsened after standard treatments. This means the cancer cells have extra copies of a gene called CCNE1, which can make the cancer grow faster.
  • The patient must be within the age range of adults, which typically means 18 years or older.
  • Both female and male patients can participate in the study.

Who cannot join the trial?

15 criteria

  • Patients who are pregnant or breastfeeding cannot participate.
  • Individuals with a history of severe allergic reactions to similar medications are excluded.
  • Patients with uncontrolled medical conditions, such as high blood pressure or diabetes, are not eligible.
  • Those who have had another cancer within the last 5 years, except for certain skin cancers, cannot join the study.
  • Participants who have received certain treatments, like chemotherapy or radiation, within a specific time frame before the study are excluded.
  • Individuals with active infections, such as hepatitis or HIV, are not allowed to participate.
  • Patients with significant heart problems, like heart failure or recent heart attacks, are excluded.
  • Those who have had major surgery within a certain period before the study cannot participate.
  • Individuals with brain metastases, which means cancer that has spread to the brain, are not eligible unless they meet specific conditions.
  • Patients who are unable to swallow pills or have gastrointestinal disorders that affect drug absorption are excluded.
  • Participants who are currently enrolled in another clinical trial are not allowed to join.
  • Individuals with a history of drug or alcohol abuse within a certain time frame before the study are excluded.
  • Patients with certain blood disorders, like low blood cell counts, are not eligible.
  • Those who have received a live vaccine within a specific period before the study cannot participate.
  • Individuals with a known history of certain genetic disorders are excluded.
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Investigated drugs

  • BLU-222

    is an investigational medication being studied for its potential to treat advanced solid tumors. It is being tested both as a single treatment and in combination with other cancer therapies. The study aims to find the best dose that patients can tolerate and to see how effective it is in fighting cancer.

  • Carboplatin

    is a chemotherapy drug used to treat various types of cancer. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing. In this trial, carboplatin is combined with BLU-222 to see if the combination is more effective than using BLU-222 alone.

  • Ribociclib

    is a medication used to treat certain types of breast cancer. It works by blocking proteins that promote cancer cell growth. In this study, ribociclib is combined with BLU-222 and another drug, fulvestrant, to evaluate the effectiveness of this combination in treating advanced solid tumors.

  • Fulvestrant

    is a hormone therapy used to treat breast cancer. It works by blocking the effects of estrogen, a hormone that can promote the growth of breast cancer cells. In this trial, fulvestrant is used in combination with BLU-222 and ribociclib to assess the potential benefits of this treatment approach for patients with advanced solid tumors.

What is already known about the treatment

BLU-222 – BLU-222 is an investigational medication administered orally, currently being studied in clinical trials for its safety, pharmacokinetics, and efficacy in treating advanced solid tumors. It is in the early phases of clinical research, with ongoing studies to determine its optimal dosing and therapeutic potential. The main therapeutic indications include HR+ breast cancer, HER2-negative breast cancer, ovarian cancer, endometrial cancer, gastric cancer, and other advanced solid tumors. BLU-222 works by targeting specific molecular pathways involved in cancer cell growth and division, potentially inhibiting tumor progression. It is classified pharmacologically as a targeted cancer therapy, aiming to disrupt cancer cell proliferation at the molecular level.

Investigated diseases

  • HR+ Breast Cancer

    Hormone receptor-positive breast cancer is a type of breast cancer that grows in response to hormones like estrogen or progesterone. It is characterized by the presence of receptors for these hormones on the surface of the cancer cells. This type of cancer tends to grow more slowly than hormone receptor-negative cancers. It can occur at any age but is more common in postmenopausal women. The progression of the disease can vary, with some cases remaining localized while others may spread to other parts of the body.

  • CCNE1 Amplification

    CCNE1 amplification refers to an increase in the number of copies of the CCNE1 gene, which can lead to uncontrolled cell division and cancer progression. This genetic alteration is often associated with aggressive tumor behavior and poor prognosis. It is commonly observed in various types of cancers, including ovarian and breast cancers. The amplification can contribute to resistance to certain cancer treatments. The progression of cancers with CCNE1 amplification can be rapid and challenging to manage.

  • HER2-negative Breast Cancer

    HER2-negative breast cancer is a type of breast cancer that tests negative for the human epidermal growth factor receptor 2 (HER2) protein. This means the cancer cells do not have an excess of the HER2 protein on their surfaces. HER2-negative cancers can be either hormone receptor-positive or triple-negative, affecting treatment options and disease progression. These cancers may grow at different rates and can spread to other parts of the body. The absence of HER2 overexpression influences the choice of targeted therapies.

  • Advanced Solid Tumor

    Advanced solid tumors refer to cancers that have progressed to a late stage, often spreading beyond their original site to other parts of the body. These tumors can arise in various organs and tissues, including the lungs, liver, and pancreas. The progression of advanced solid tumors can be aggressive, with symptoms depending on the location and size of the tumor. They often require complex treatment strategies due to their advanced nature. The growth and spread of these tumors can significantly impact the patient's quality of life.

  • Ovarian Cancer

    Ovarian cancer originates in the ovaries and is often detected at an advanced stage due to subtle early symptoms. It can spread to the pelvis and abdomen, making it more challenging to treat. The disease is characterized by the uncontrolled growth of cells in the ovaries, which can form tumors. Ovarian cancer can progress rapidly, affecting nearby organs and tissues. The progression and symptoms can vary, with some cases remaining localized while others metastasize.

  • Endometrial Cancer

    Endometrial cancer begins in the lining of the uterus, known as the endometrium. It is the most common type of uterine cancer and often presents with symptoms like abnormal vaginal bleeding. The disease typically progresses slowly, but some aggressive forms can spread to other parts of the body. Risk factors include obesity, hormone imbalances, and certain genetic conditions. The progression of endometrial cancer can vary, with early detection often leading to better outcomes.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2022-502528-29-00Protocol codeBLU-222-1101Estimated enrolment366 patientsSponsorBlueprint Medicines Corp.

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