Great progress has been made in the treatment of patients with advanced non-small cell lung cancer (NSCLC) and colorectal cancer over the past few years. However, the therapy options are limited if the condition continues to advance despite chemotherapy and drug immunotherapy. For patients with advanced soft tissue sarcoma (STS), the options are still limited to chemotherapy.

The IP-IIO-622_SAKK 69/22 trial will investigate a treatment approach for when immunotherapy and chemotherapy are no longer effective: the thermal ablation of a tumor followed by injection of the trial medication IP-001 directly into the pre-treated tumor.

• Thermal ablation is a frequently used treatment method for various types of cancer. Thermal ablation uses a probe that is inserted directly into the tumor to generate high temperatures (thermal) to destroy cancer cells locally. The surrounding healthy tissue remains undamaged.
• The trial medication being investigated, IP-001, is an immunostimulant that is not yet authorized.

Previous trials have shown that the combination of the trial product and thermal ablation may help the immune system (the body's defense system) be effective against cancer and destroy the remaining cancer cells (located some distance away from the tumor) in the body.

Focus on safety and efficacy

The main aim of the trial is to establish how safe the trial medication is and how well it is tolerated following thermal ablation. The trial will also examine

• how effective the trial medication is in the treatment of cancer,
• how the body processes the trial medication,
• how the immune system responds to the trial medication,
• what quantity of the trial medication is present in the blood over a specific period of time (known as pharmacokinetics).

Blood and tumor tissue samples will therefore be taken and analyzed in more detail during the course of the trial to better understand the immune response and the mechanism of action of the therapy.