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Study of INBRX-109 with Irinotecan Hydrochloride Trihydrate and Temozolomide for Patients with Advanced Solid Tumors, Including Sarcomas

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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 INBRX-109 in patients with advanced or metastatic solid tumors, including a type of cancer known as Sarcomas. The study aims to understand how safe and tolerable INBRX-109 is when given through an intravenous infusion, which means it is administered directly into the bloodstream. The trial will also explore how effective this treatment is in shrinking tumors, particularly in patients with a specific type of sarcoma called Ewing sarcoma, as well as in those with SDH-deficient solid tumors or GIST (Gastrointestinal Stromal Tumors).

Participants in the study will receive INBRX-109 in combination with other chemotherapy drugs, such as irinotecan hydrochloride trihydrate and temozolomide. These medications are designed to work together to target and destroy cancer cells. The study will monitor the participants over a period to observe any changes in their condition and to record any side effects they may experience. The goal is to determine the best dose of INBRX-109 that can be given safely and to see how well it works in treating these types of cancers.

The trial is open to adults and adolescents who have been diagnosed with these advanced cancers and have limited treatment options. By participating, researchers hope to gather valuable information that could lead to new and improved treatments for these challenging conditions. The study will continue until enough data is collected to make informed conclusions about the safety and effectiveness of INBRX-109 in combination with other treatments.

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

    Initial treatment phase

    The study begins with the administration of INBRX-109, a monoclonal antibody, through an intravenous infusion. This is done to evaluate its safety and how well it is tolerated.

    During this phase, the dosage of INBRX-109 may be adjusted based on individual response and any side effects experienced.

  2. Step 2

    Combination therapy phase

    Following the initial treatment, INBRX-109 is combined with other medications, including irinotecan hydrochloride trihydrate and temozolomide. These are administered to assess their combined effect on the tumor.

    The irinotecan hydrochloride trihydrate is given as an intravenous infusion, while temozolomide is taken orally in capsule form.

  3. Step 3

    Monitoring and assessment

    Throughout the trial, regular monitoring is conducted to observe the body's response to the treatment. This includes assessing any side effects and measuring the size of the tumor.

    The effectiveness of the treatment is evaluated using criteria such as the objective response rate and the duration of response.

  4. Step 4

    Follow-up phase

    After completing the treatment cycles, follow-up visits are scheduled to continue monitoring the patient's health and any long-term effects of the treatment.

    These visits help in understanding the overall impact of the treatment on the disease and the patient's quality of life.

Who can join the trial?

13 criteria

  • Participants must be males or females aged 12 to less than 85 years for Ewing sarcoma, and 18 to less than 85 years for other tumors. They must weigh at least 30 kg.
  • Participants should have an estimated life expectancy of at least 12 weeks, as judged by the study doctor.
  • Participants who can have children must agree to use effective birth control methods starting 28 days before the first dose of the study treatment and continuing until 90 days after the last dose. Men must not donate sperm during this time.
  • Participants must have recovered from any side effects of previous cancer treatments to a certain level, except for some non-serious conditions like hair loss or mild nerve damage.
  • Participants must be able to understand and sign a consent form before starting any study procedures.
  • Participants with Ewing sarcoma must have a confirmed diagnosis and have received 1 to 2 prior treatments. They must have a specific genetic rearrangement confirmed by a lab and provide tissue samples.
  • Participants with SDH-deficient solid tumors or GIST must have a confirmed diagnosis and provide tissue samples. They must have no known curative therapy available.
  • Participants must have measurable disease, meaning the tumor can be measured using specific criteria.
  • Participants must have adequate liver function, with specific blood test results within certain limits.
  • Participants must have adequate kidney function, with a certain level of creatinine clearance, which is a measure of kidney health.
  • Participants must have adequate blood cell counts, including a certain level of neutrophils, platelets, and hemoglobin.
  • Participants must have normal blood clotting ability, with specific test results within certain limits.
  • Participants must have a good performance status, meaning they are able to carry out daily activities with little or no assistance. Exceptions can be made for active individuals with mobility issues due to past cancer surgeries.

Who cannot join the trial?

12 criteria

  • Patients who have not been diagnosed with advanced or metastatic solid tumors. This means the cancer has not spread to other parts of the body.
  • Patients who are not adults or adolescents. This trial is only for individuals in these age groups.
  • Patients who are not able to receive the treatment through an IV (intravenous) method, which means the medicine is given directly into a vein.
  • Patients who do not have Ewing sarcoma, SDH-deficient solid tumors, or GIST. These are specific types of tumors required for the study.
  • Patients who are not able to safely tolerate the combination of INBRX-109 with other chemotherapies.
  • Patients who are not able to provide consent or do not have a legal guardian to provide consent on their behalf.
  • Patients who are pregnant or breastfeeding, as the effects on unborn or nursing children are unknown.
  • Patients who have other medical conditions that might interfere with the study or make participation unsafe.
  • Patients who are currently participating in another clinical trial or have recently participated in one.
  • Patients who have had a recent major surgery or are recovering from one.
  • Patients who have a history of allergic reactions to similar treatments or medications.
  • Patients who have not met the required health and safety assessments needed to participate in the trial.
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Investigated drugs

INBRX-109 is an experimental medication being tested for its safety and effectiveness in treating advanced or metastatic solid tumors, including sarcomas. It is administered through an intravenous (IV) infusion. The study aims to determine how well this medication works in shrinking tumors and how long the effects last, particularly in patients with Ewing sarcoma and other specific types of tumors.

What is already known about the treatment

INBRX-109 – This medication is administered intravenously and is currently being studied in clinical trials for its safety and effectiveness in treating advanced or metastatic solid tumors, including sarcomas. It is in the early stages of research, specifically a Phase 1 trial, which aims to determine its safety and tolerability. The main therapeutic indication for INBRX-109 is for patients with advanced or metastatic solid tumors, such as Ewing sarcoma and SDH-deficient tumors. At the molecular level, INBRX-109 works by targeting specific proteins involved in tumor growth, although the exact mechanism is still under investigation. It is classified pharmacologically as a monoclonal antibody, which is a type of targeted therapy designed to interfere with cancer cell growth.

Investigated diseases

  • Ewing Sarcoma

    Ewing sarcoma is a rare type of cancer that occurs in bones or in the soft tissue around the bones. It primarily affects children and young adults. The disease often begins in the long bones of the arms and legs, pelvis, or chest. It can cause pain, swelling, and sometimes a palpable lump. As it progresses, it may spread to other parts of the body, including the lungs and other bones. Early detection is crucial for managing the disease effectively.

  • SDH-Deficient Solid Tumors

    SDH-deficient solid tumors are a group of rare tumors characterized by the loss of function of the succinate dehydrogenase (SDH) enzyme complex. These tumors can occur in various parts of the body, including the gastrointestinal tract and adrenal glands. They may grow slowly and often do not cause symptoms until they are large. As they develop, they can lead to symptoms related to the pressure they exert on nearby organs. The progression of these tumors can vary significantly depending on their location and size. Understanding the genetic basis of these tumors is important for their management.

  • Gastrointestinal Stromal Tumors (GIST)

    Gastrointestinal stromal tumors (GIST) are a type of tumor that occurs in the digestive tract, most commonly in the stomach or small intestine. They arise from specialized cells in the gastrointestinal tract wall known as interstitial cells of Cajal. GISTs can vary in size and may cause symptoms such as abdominal pain, bleeding, or obstruction. As they grow, they can invade nearby structures or spread to other parts of the body. The behavior of GISTs can range from benign to aggressive, depending on their size and location. Understanding their molecular characteristics is key to managing the disease.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-508139-29-00Protocol codePh1 INBRX-109 Part 3Estimated enrolment270 patientsSponsorInhibrx Biosciences Inc.

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