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Study on the Safety and Effects of THOR-707 and Drug Combination in Adults with Advanced or Metastatic 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 the safety and effectiveness of a new treatment called THOR-707 for adults with advanced or metastatic solid tumors, which are types of cancer that have spread to other parts of the body. The study will explore how well THOR-707 works on its own and in combination with other treatments. The main goal is to understand how safe the treatment is and to find the best dose that can be used in future studies.

Participants in the study will receive THOR-707 either by itself or alongside other medications, such as Diphenhydramine, Ondansetron, Dexamethasone, Tocilizumab, Famotidine, and a combination of Buclizine Hydrochloride, Paracetamol, and Codeine Phosphate. Another treatment being tested is Pegenzileukin, which is given through an infusion, meaning it is delivered directly into the bloodstream. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the new treatment.

The study will take place over several phases, starting with a dose escalation phase to determine the safest and most effective dose of THOR-707. Participants will be closely monitored for any side effects and the treatment's impact on their cancer. The study aims to gather information on how the treatment affects tumor growth and overall health. This research is important for developing new cancer treatments and improving outcomes for patients with advanced cancer.

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, eligibility is confirmed based on specific criteria such as having a measurable disease, a life expectancy of at least 12 weeks, and adequate organ function.

    Participants must agree to use birth control during the study and for a specified period after the last dose of the study medication.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline health status. This includes a physical examination, blood tests, and imaging studies to measure the disease.

  3. Step 3

    Treatment phase

    The treatment involves the administration of THOR-707 either as a single agent or in combination with other medications.

    Medications such as tocilizumab, famotidine, pegenzileukin, and paracetamol may be used. The administration routes include intravenous and oral use.

    The dosage and frequency depend on the specific cohort and the phase of the trial. The goal is to determine the maximum tolerated dose and the recommended dose for future studies.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for any side effects or adverse reactions. Regular follow-up visits are scheduled to assess the response to treatment.

    The study aims to evaluate the safety and effectiveness of the treatment, including the rate of dose-limiting toxicities and the overall response rate.

  5. Step 5

    End of treatment

    At the end of the treatment phase, a final assessment is conducted to evaluate the overall health status and the effect of the treatment on the disease.

    Participants may be asked to continue follow-up visits to monitor long-term outcomes and any delayed side effects.

Who can join the trial?

11 criteria

  • Participants must have a **measurable disease** according to specific criteria. This means the cancer can be measured in size using medical imaging.
  • For women who can have children, a **negative pregnancy test** is required within 7 days before starting the study treatment.
  • Men must agree not to donate or store sperm during the treatment and for at least 3 days after the last dose.
  • Participants must have a **life expectancy** of at least 12 weeks.
  • Participants should have a **performance status** of 0 or 1, which means they are fully active or have some restrictions but can still do light work.
  • Participants must have **adequate heart, blood, liver, and kidney function**.
  • Participants must have a confirmed diagnosis of advanced or metastatic solid tumors, which means the cancer has spread to other parts of the body.
  • Participants must have at least one tumor that can be safely biopsied, which means a small sample can be taken for testing.
  • Participants with advanced or metastatic solid tumors who have refused standard care, or for whom no reasonable standard care exists, or for whom standard therapy is not effective, intolerable, or not accessible.
  • Previous cancer treatments are allowed if any side effects from those treatments have been resolved to an acceptable level.
  • Women who can have children and men who are not surgically sterile must agree to use a medically accepted method of birth control during the study and for a specified time after the last dose, depending on the study group they are in.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have had a severe allergic reaction to similar treatments in the past.
  • Patients who are currently pregnant or breastfeeding.
  • Patients who have another serious illness that could interfere with the study.
  • Patients who are taking medications that might interact with the study treatment.
  • Patients who have participated in another clinical trial recently.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have an infection that is not well controlled.
  • Patients who have a condition that affects their immune system.
  • Patients who have had a major surgery recently.
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Investigated drugs

THOR-707 is an investigational medication being studied for its potential to treat advanced or metastatic solid tumors. In this clinical trial, researchers are examining how safe and tolerable THOR-707 is when used alone and in combination with other therapies. They are also trying to determine the best dose to use in future studies. Additionally, the trial aims to see how well THOR-707 works against tumors by measuring the response rate in patients.

What is already known about the treatment

THOR-707 – THOR-707 is administered through injection and is currently being studied in clinical trials for its potential use in treating advanced or metastatic solid tumors, particularly in cancer patients. It is in the early stages of clinical research, specifically Phase 1/2 trials, where its safety, tolerability, and preliminary anti-tumor activity are being evaluated. The main therapeutic indication for THOR-707 is cancer, and it works by enhancing the immune system's ability to target and destroy cancer cells. It belongs to the pharmacological class of immunotherapy agents, which are designed to boost the body's natural defenses to fight cancer.

Investigated diseases

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells in the body. These cells can invade nearby tissues and form tumors, which may disrupt normal bodily functions. As cancer progresses, it can metastasize, meaning it spreads to other parts of the body through the blood or lymphatic system. The progression of cancer varies depending on the type and location of the cancer, as well as individual factors. Some cancers grow slowly and may not cause symptoms for a long time, while others can grow rapidly and cause significant health issues. The behavior and progression of cancer are influenced by genetic, environmental, and lifestyle factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-508422-95-00Protocol codeTCD16843Estimated enrolment294 patientsSponsorSynthorx Inc.

sourced from the EU Clinical Trials Register and site verification

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