REGN7075 + Cemiplimab for Advanced Cancer

(COMBINE-EGFR-1 Trial)

This trial tests a new drug, REGN7075 (an EGFRxCD28 costimulatory bispecific antibody), both alone and with cemiplimab (also known as Libtayo), to determine their effectiveness in treating certain advanced solid tumors. Researchers aim to identify the safest and most effective dose of REGN7075, either alone or with cemiplimab, and to understand its mechanism in the body and its side effects. Individuals with certain advanced cancers, such as specific lung or breast cancers, who have not previously received PD-1/PD-L1 drugs, may qualify. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new therapy.

The trial requires that you stop taking certain medications before starting, such as any approved systemic therapy, recent anti-EGFR antibody therapy, or previous systemic non-immunomodulatory biologic therapy within 4 weeks of the study drug. If you're on corticosteroids, you may need to stop or reduce them 1-2 weeks before starting the trial.

Research has shown that REGN7075, when combined with cemiplimab, demonstrates promising safety results. In earlier studies, no patients experienced serious side effects that limited the dose, indicating the treatment was well-tolerated at the tested amounts. Cemiplimab, already approved for some cancers, has a known safety record. Serious side effects occurred in about 25% of patients, similar to other cancer treatments. Overall, these findings suggest that both REGN7075 and cemiplimab are generally well-tolerated, with manageable side effects.¹²³⁴⁵

Researchers are excited about Cemiplimab and REGN7075 for advanced cancer because they work in a unique way compared to standard treatments. Cemiplimab is an immune checkpoint inhibitor that unleashes the body's T-cells to attack cancer by blocking the PD-1 pathway, a mechanism not used by traditional chemotherapy. REGN7075 is an innovative bispecific antibody that connects T-cells directly to cancer cells, potentially enhancing the immune attack. This combination could offer a more targeted and robust approach to fighting various types of cancer, including those that are resistant to current therapies.

Research has shown that REGN7075, a new type of antibody, may help treat tumors that typically resist the immune system. Participants in this trial may receive REGN7075, which has shown promise in treating a challenging type of colorectal cancer, even when it has metastasized to the liver. Another treatment option in this trial is cemiplimab, which past studies have found to shrink tumors. Specifically, cemiplimab completely eliminated tumors in 20% of patients and reduced them in 27% of patients with advanced cancers. This trial will explore combining REGN7075 with cemiplimab to enhance the immune system's response to advanced solid tumors, offering hope for improved treatment outcomes.⁶⁷⁸⁹¹⁰