L19IL2 + L19TNF for Basal Cell Carcinoma

This trial aims to test the effectiveness and safety of new treatments for people with basal cell carcinoma (BCC) who can't or choose not to undergo surgery or radiation. The study will explore three treatments: L19IL2 alone, L19TNF alone, or a combination of both, delivered through direct injections into the tumor. Ideal participants are those with advanced BCC, who have an injectable tumor and have not received certain immune treatments before.

As a Phase 2 trial, the research focuses on measuring how well the treatment works in an initial, smaller group of people.

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently on topical or systemic chemotherapy, targeted therapy, or immunotherapy. It's best to discuss your specific medications with the trial team.

Studies have shown that combining L19IL2 and L19TNF is generally well-tolerated in patients with hard-to-treat non-melanoma skin cancer. Reports indicate a favorable safety profile, with most patients not experiencing severe side effects. Previous research suggests that L19IL2 alone can be safely administered at certain doses to patients with advanced solid tumors. Additionally, when injected directly into the tumor, L19TNF has demonstrated a manageable safety profile. Overall, data from these studies suggest that these treatments are relatively safe for humans, with most side effects being mild or moderate.¹²³⁴⁵

Unlike the standard treatments for basal cell carcinoma, which typically involve surgical removal or topical therapies, L19IL2 and L19TNF offer a novel approach by using targeted intralesional injections. These investigational drugs are designed to enhance the body's immune response directly at the tumor site. L19IL2 is a fusion protein that delivers interleukin-2 (IL2) to stimulate immune cells, while L19TNF delivers tumor necrosis factor (TNF) to attack cancer cells. The combination of L19IL2 and L19TNF is particularly exciting because it may provide a more potent response by simultaneously boosting the immune system and directly targeting cancer cells. Researchers are hopeful that these treatments will offer a less invasive and potentially more effective option for patients.

This trial will evaluate the effectiveness of different treatments for basal cell carcinoma. Participants in one arm will receive a combination of L19IL2 and L19TNF, which research suggests may help treat this type of skin cancer. Earlier studies found that injecting this combination directly into the tumor was safe and showed early signs of effectiveness for difficult-to-treat skin cancers. Another arm will involve L19IL2 alone, which has also produced positive results, with some patients experiencing significant improvement. A separate arm will test L19TNF alone, which has shown potential to shrink tumors or halt their growth. Overall, these treatments aim to directly target cancer cells and enhance the immune system's ability to fight the cancer more effectively.¹²⁴⁶⁷