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Study on the Effectiveness and Safety of INT230-6 (Vinblastine Sulfate, Cisplatin) for Adults with Metastatic Soft Tissue 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 effectiveness and safety of a new treatment called INT230-6 for patients with certain types of soft tissue sarcomas. Soft tissue sarcomas are a group of cancers that begin in the tissues that connect, support, or surround other structures and organs of the body. The specific types of sarcomas being studied include liposarcoma, undifferentiated pleomorphic sarcoma, and leiomyosarcoma. The treatment INT230-6 is a combination of two substances, vinblastine sulfate and cisplatin, which are administered directly into the tumor.

The purpose of the study is to compare the new treatment, INT230-6, with the standard care currently used in the United States for these types of sarcomas. Participants in the study will receive either the new treatment or the standard care, which may include other medications such as Halaven, Trabectedin, or Pazopanib. The study will last for a period of up to 24 months, during which the participants' health and response to the treatment will be closely monitored.

This trial aims to provide valuable information on whether INT230-6 can improve the overall survival of patients with these challenging types of cancer. The study will also look at the side effects and overall quality of life of the participants during the treatment period. By participating in this study, researchers hope to find more effective ways to treat soft tissue sarcomas and improve outcomes for patients 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

    Joining the study

    Upon joining the study, the participant will be randomly assigned to receive either the investigational treatment INT230-6 or the standard care treatment.

    The participant must be at least 18 years old and have a confirmed diagnosis of specific types of soft tissue sarcomas, such as liposarcoma, leiomyosarcoma, or undifferentiated pleomorphic sarcoma.

  2. Step 2

    Treatment administration

    The investigational treatment INT230-6 is administered directly into the tumor through an injection. This treatment includes a combination of vinblastine sulfate and cisplatin.

    Participants receiving standard care may be treated with medications such as eribulin, trabectedin, or pazopanib. Eribulin is given as an intravenous injection, trabectedin as an intravenous infusion, and pazopanib is taken orally as a tablet.

  3. Step 3

    Treatment schedule

    The frequency and duration of the treatment will depend on the specific protocol assigned to the participant. The study aims to compare the overall survival of participants receiving INT230-6 with those receiving standard care.

  4. Step 4

    Monitoring and assessments

    Participants will undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes imaging tests to measure tumor size and blood tests to check organ function.

    Participants will also be evaluated for any side effects or adverse events related to the treatment.

  5. Step 5

    Study duration

    The study is expected to continue until December 31, 2027. Participants will be followed up regularly throughout the study period to monitor their health and response to treatment.

Who can join the trial?

9 criteria

  • The participant can be of any sex and must be at least 18 years old. They must provide written consent to join the study. In some cases, a legally acceptable representative can provide consent, except in Germany where the participant must provide consent themselves.
  • The participant must have a confirmed diagnosis of a specific type of cancer called **soft tissue sarcoma (STS)**, which includes subtypes like **liposarcoma**, **leiomyosarcoma**, and **undifferentiated pleomorphic sarcoma**. The cancer must be unresectable (cannot be removed by surgery), locally advanced, or metastatic (spread to other parts of the body).
  • The participant must have received at least one previous treatment for advanced STS and must have shown disease progression after treatments like **anthracycline-based therapy**. They should not have had more than two previous treatments for unresectable, locally advanced, or metastatic STS.
  • The participant must have a measurable disease according to specific criteria called **RECIST 1.1**.
  • The participant must have at least one tumor that can be targeted for injection, which is at least 2 cm in size and can be measured by **CT** or **MRI** scans.
  • The participant must have an **ECOG performance status** of 0, 1, or 2, which is a scale used to assess how a disease affects a patient's daily living abilities.
  • The participant must have adequate organ function, which will be checked through various blood tests. These tests include checking levels of neutrophils, platelets, hemoglobin, creatinine, liver enzymes (ALT and AST), bilirubin, and creatine phosphokinase.
  • Female participants must not be pregnant or breastfeeding. They must either not be of childbearing potential or agree to use effective contraception during the study and for at least 7 months after the study ends.
  • Male participants with female partners who can become pregnant must agree to use contraception and refrain from donating sperm during the study and for 6 months after the study ends.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer not specified in the study.
  • Patients who have had a recent major surgery or procedure.
  • Patients with severe heart problems.
  • Patients with uncontrolled infections.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures.
  • Patients who have participated in another clinical trial recently.
  • Patients with a history of allergic reactions to the study medication.
  • Patients with severe liver or kidney disease.
  • Patients with a history of drug or alcohol abuse.
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Investigated drugs

INT230-6 is a combination therapy that is injected directly into tumors. It includes three components: SHAO, which is a proprietary formulation, and two chemotherapy drugs, Vinblastine and Cisplatin. This therapy is being tested to see if it can effectively treat soft tissue sarcomas that cannot be removed by surgery or have spread to other parts of the body. The goal is to see if this treatment can help patients live longer compared to the standard treatments used in the United States.

What is already known about the treatment

INT230-6 – This medication is administered directly into the tumor, known as intratumoral administration. It is currently being studied in clinical trials for its effectiveness and safety in treating certain types of soft tissue sarcomas, including liposarcoma, undifferentiated pleomorphic sarcoma, and leiomyosarcoma. The main therapeutic indication is for patients with locally recurrent, inoperable, or metastatic forms of these sarcomas. INT230-6 works by combining three components: SHAO, vinblastine, and cisplatin, which together aim to destroy cancer cells by disrupting their DNA and inhibiting cell division. It is classified pharmacologically as a combination chemotherapy agent.

Investigated diseases

  • Liposarcoma

    A type of cancer that arises in fat cells, often occurring in the deep soft tissues of the body, such as the thighs or retroperitoneum. It can be classified into subtypes like dedifferentiated, myxoid, round cell, or pleomorphic, each with distinct cellular characteristics. The disease typically presents as a painless, enlarging mass, and its progression can vary depending on the subtype. Over time, the tumor may grow and potentially invade surrounding tissues or metastasize to other parts of the body.

  • Undifferentiated Pleomorphic Sarcoma

    A rare type of soft tissue sarcoma that lacks specific differentiation, making it difficult to classify under a specific cell type. It often presents as a rapidly growing mass, usually in the extremities or retroperitoneum. The disease is characterized by a high degree of cellular atypia and pleomorphism, meaning the cells vary widely in shape and size. As it progresses, it may invade nearby tissues and has the potential to spread to distant sites.

  • Leiomyosarcoma

    A malignant tumor that originates from smooth muscle cells, commonly found in the uterus, gastrointestinal tract, or blood vessels, but can occur in other non-uterine locations. It typically presents as a firm, painless mass and may cause symptoms related to the compression of nearby structures. The disease is known for its aggressive nature and potential to metastasize, particularly to the lungs and liver. As it advances, it can lead to significant local tissue destruction and distant spread.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512423-36-00Protocol codeIT-03Estimated enrolment333 patientsSponsorIntensity Therapeutics Inc.

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