Wednesday, May 31, 2023
Debiopharm, a privately-owned biopharmaceutical company headquartered in Switzerland, has announced the initiation of a Phase 1 clinical study for Debio 0123 in small cell lung cancer (SCLC). The study aims to evaluate the effectiveness of Debio 0123, a WEE1 inhibitor that can be taken orally and has high selectivity and brain penetrance. The clinical trial will investigate the combination of Debio 0123 with carboplatin and etoposide in patients with recurrent or progressive SCLC following standard platinum-based chemotherapy.
The Phase 1 study, known as NCT05815160 (Debio 0123-SCLC-104), comprises two parts: a dose escalation phase to determine the recommended dosage and an expansion phase to assess the safety, tolerability, and initial signs of antitumoral activity of Debio 0123 in combination with carboplatin and etoposide for this specific patient population.
SCLC is a highly aggressive and challenging form of lung cancer with a poor prognosis, accounting for approximately 15% of all lung cancer cases. It is characterized by rapid growth, early metastasis, and significant genetic diversity within the tumor, which contributes to treatment resistance. Targeting the DNA damage response (DDR) pathway has shown promise in combination with DNA-damaging agents like carboplatin and etoposide for the treatment of SCLC.
Debio 0123 is part of Debiopharm's ongoing efforts to explore DDR inhibition as a potential therapeutic strategy for life-threatening cancers. The clinical development of Debio 0123 aims to optimize efficacy while ensuring patient safety. If successful, Debio 0123 could become a promising WEE1 inhibitor for the treatment of SCLC.
Dr. Luis Paz-Ares Rodríguez, the Coordinating Investigator for the study, expressed hope that the combination of Debio 0123 with current standard-of-care treatments may extend the lives of patients with recurrent SCLC. Dr. Esteban Rodrigo Imedio, Senior Medical Director of Oncology Research & Development at Debiopharm, believes that this combination therapy has the potential to enhance antitumoral activity and delay resistance to carboplatin and etoposide.
SCLC is a leading cause of cancer-related deaths globally, with an estimated 250,000 new cases and 200,000 deaths annually. The disease predominantly affects older men, although there has been a rise in the proportion of cases among women due to increased tobacco consumption. Despite numerous clinical trials over the past three decades aimed at improving SCLC therapies, the prognosis for this disease remains poor, with a median overall survival of up to 13 months for patients receiving standard care.