Metastasis Trials in Disease

Study on the Safety and Effects of THOR-707 and Drug Combination in Adults with Advanced or Metastatic Cancer

This clinical trial is investigating a new treatment approach for adults with advanced or metastatic solid tumors, meaning cancers that have spread from their original location to other parts of the body. The study focuses on understanding how safe and effective THOR-707 is, both when used alone and in combination with other medications.

Main inclusion criteria:

• Participants must have a confirmed diagnosis of advanced or metastatic solid tumors
• The disease must be measurable using medical imaging
• A life expectancy of at least 12 weeks is required
• Participants should be fully active or have only some restrictions but still able to do light work
• Adequate heart, blood, liver, and kidney function is necessary
• At least one tumor must be accessible for safe biopsy (tissue sample collection)
• The trial is open to patients who have refused standard care, for whom no reasonable standard treatment exists, or for whom standard therapy has not worked or caused intolerable side effects
• Women of childbearing potential must have a negative pregnancy test within 7 days before starting treatment
• Participants must agree to use medically accepted birth control methods during the study and for a specified time afterward

Main exclusion criteria:

• Having a different type of cancer than the one being studied
• History of severe allergic reactions to similar treatments
• Currently pregnant or breastfeeding
• Having another serious illness that could interfere with the study
• Taking medications that might interact with the study treatment
• Recent participation in another clinical trial
• History of drug or alcohol abuse
• Uncontrolled infection
• Conditions affecting the immune system
• Recent major surgery

Focus and goal of the trial:

The primary goal is to determine the safest and most effective dose of THOR-707 for future studies. The trial is divided into several phases. Initially, participants undergo eligibility confirmation and baseline health assessments, including physical examinations, blood tests, and imaging studies. During the treatment phase, THOR-707 is administered either alone or in combination with other medications such as tocilizumab, famotidine, pegenzileukin, and paracetamol. The administration can be through intravenous infusion (directly into the bloodstream) or orally.

Throughout the study, participants are closely monitored for side effects and the treatment's impact on their cancer. Regular follow-up visits assess how well the treatment is working and track any adverse reactions. The study aims to evaluate dose-limiting toxicities and overall response rates. At the end of the treatment phase, a final assessment is conducted, and participants may continue with follow-up visits to monitor long-term outcomes.

Investigational drug:

The main investigational drug being tested is THOR-707, an immunotherapy agent administered by injection. THOR-707 works by enhancing the immune system's ability to target and destroy cancer cells. This is an early-stage clinical research study (Phase 1/2), focusing on establishing the safety, tolerability, and preliminary anti-tumor activity of the treatment. Some participants may also receive a placebo (a substance with no active medication) for comparison purposes, and various supportive medications may be used alongside THOR-707 to manage side effects and improve treatment outcomes.

Summary

Currently, there is one active clinical trial available for patients with metastatic cancer, located in Spain. This trial represents an important step in developing new immunotherapy approaches for advanced cancer patients who have limited treatment options. The study focuses on THOR-707, a novel investigational drug designed to boost the immune system's ability to fight cancer. The trial is in its early phases and aims to establish the foundation for future research by determining the optimal dose and assessing safety profiles. Patients interested in participating should discuss eligibility requirements with their healthcare provider, particularly regarding disease characteristics, overall health status, and previous treatment history.