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Study on the Safety of LSTA1 with Standard Care for Patients with Advanced Head and Neck Cancer or Cholangiocarcinoma

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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 LSTA1 in combination with standard care for patients with advanced solid tumors, specifically head and neck cancer and cholangiocarcinoma, which is a type of bile duct cancer. The study aims to evaluate the safety of adding LSTA1 to the usual treatments compared to using the usual treatments alone. The usual treatments, also known as standard of care, may include medications like gemcitabine, durvalumab, cisplatin, and paclitaxel, which are commonly used in chemotherapy.

Participants in the study will be randomly assigned to receive either the new treatment with LSTA1 or a placebo, along with their standard care. The study will be conducted over a period of up to 52 weeks, during which participants will receive their assigned treatments through intravenous infusions. The study will monitor the incidence and severity of any side effects, as well as other outcomes such as overall survival, progression-free survival, and response to the treatment.

The goal of this research is to determine if the addition of LSTA1 can improve the outcomes for patients with these types of cancers. By participating in this study, researchers hope to gather valuable information that could lead to better treatment options in the future. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the new treatment or the placebo, to ensure unbiased results.

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, you will be randomly assigned to one of two groups. One group will receive the standard treatment, and the other group will receive the standard treatment plus an additional medication called LSTA1.

  2. Step 2

    Treatment administration

    You will receive your treatment through an intravenous (IV) infusion. This means the medication will be given directly into your bloodstream through a vein.

    The standard treatment may include medications such as gemcitabine, durvalumab, cisplatin, and paclitaxel. The specific medications and their dosages will depend on your individual treatment plan.

  3. Step 3

    Treatment schedule

    The frequency and duration of your treatment will be determined by your healthcare team. It is important to attend all scheduled appointments to ensure the effectiveness of the treatment.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, your health will be closely monitored. This includes regular check-ups, blood tests, and imaging studies to assess how your body is responding to the treatment.

    You will be asked to report any side effects or changes in your health to your healthcare team immediately.

  5. Step 5

    End of study participation

    At the end of your participation in the study, you will have a final evaluation to assess your overall health and the outcomes of the treatment.

    Your healthcare team will discuss the results with you and provide guidance on any further treatment or follow-up care that may be needed.

Who can join the trial?

10 criteria

  • Must be 18 years or older and able to give consent to participate.
  • Must have a primary tumor located in the oropharynx, oral cavity, hypopharynx, or larynx. Tumors in the skin, paranasal sinuses, or nasopharynx are not eligible.
  • For cholangiocarcinoma (a type of cancer in the bile ducts) or gallbladder cancer, the cancer must be metastatic (spread to other parts of the body) or cannot be removed by surgery. No previous treatments like chemotherapy or targeted therapy should have been given, except if the disease returned more than 6 months after completing chemotherapy following surgery.
  • If the patient had a procedure to relieve bile duct blockage in the last 14 days, the bilirubin level (a substance made by the liver) must be stable, with two similar test results taken 5 to 7 days apart.
  • Must have an ECOG Performance Status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Must have a life expectancy of at least 3 months, as judged by the doctor.
  • Must have at least one measurable cancer lesion that can be assessed by a specific method called RECIST 1.1. Lesions in areas previously treated with radiation or other local treatments are generally not measurable unless they have clearly grown or persisted for three months after treatment.
  • Must have adequate organ and bone marrow function, which includes specific levels of blood cells, liver enzymes, and other health indicators.
  • Must agree to use adequate contraception if of childbearing potential, to prevent pregnancy during the study and for a specified period after the last dose of the study drug.
  • For head and neck squamous cell carcinoma (HNSCC), the cancer must be recurrent or metastatic, cannot be removed by surgery, and must have progressed after first-line immunotherapy. The tumor must be tested for a specific protein called PD-L1, and the patient must have received prior treatment with checkpoint inhibitors.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer besides head and neck cancer or cholangiocarcinoma (a type of bile duct cancer) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to follow the study procedures or instructions cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with certain medical conditions that might interfere with the study cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had a recent major surgery or are planning to have surgery during the study cannot participate.
  • Patients with a history of severe allergic reactions to any of the study medications cannot participate.
  • Patients with uncontrolled infections or other serious illnesses cannot participate.
  • Patients who have a history of drug or alcohol abuse cannot participate.
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Investigated drugs

LSTA1 is an experimental medication being tested to see if it can help treat advanced solid tumors. It is being studied to understand if it can improve the effects of standard cancer treatments. The goal is to see if adding LSTA1 to the usual treatments can make them work better or be safer for patients with advanced cancer.

What is already known about the treatment

LSTA1 – LSTA1 is administered as an addition to standard cancer treatments, typically given through an intravenous infusion, which means it's delivered directly into the bloodstream. Currently, LSTA1 is being studied in clinical trials to assess its safety and effectiveness when combined with standard treatments for advanced solid tumors, including head and neck cancer and cholangiocarcinoma. The main goal of using LSTA1 is to enhance the effects of existing cancer therapies, potentially improving outcomes for patients. At the molecular level, LSTA1 works by targeting specific pathways in cancer cells, making them more susceptible to treatment. It is classified as an investigational drug, meaning it is still under study and not yet approved for general medical use.

Investigated diseases

  • Head and Neck Cancer

    Head and neck cancer refers to a group of cancers that originate in the tissues and organs of the head and neck region, such as the throat, larynx, nose, sinuses, and mouth. These cancers typically begin in the squamous cells that line the moist surfaces inside the head and neck. As the disease progresses, it can invade nearby tissues and spread to lymph nodes in the neck. The progression may lead to symptoms such as a persistent sore throat, difficulty swallowing, and changes in voice. Advanced stages can involve further spread to other parts of the body. The rate of progression and specific symptoms can vary depending on the exact location and type of cancer.

  • Cholangiocarcinoma

    Cholangiocarcinoma is a cancer that forms in the bile ducts, which are the tubes that carry bile from the liver to the gallbladder and small intestine. This cancer can occur anywhere along the bile ducts and is classified based on its location as intrahepatic, perihilar, or distal. As cholangiocarcinoma progresses, it can cause symptoms such as jaundice, abdominal pain, and weight loss. The disease may spread to nearby organs and tissues, including the liver and lymph nodes. The progression of cholangiocarcinoma can vary, with some cases growing slowly while others advance more rapidly. The specific symptoms and progression depend on the tumor's location and size.

Trial detailsLast updated 5 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503740-14-00Protocol codeLSTA1-P02Estimated enrolment80 patientsSponsorLisata Therapeutics Inc.

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