Combination of Nelmastobart and Capecitabine Therapy in Metastatic Colorectal Cancer

Colorectal cancer is the third most commonly diagnosed cancer in men and the second most common cancer in women worldwide, with an estimated 1.9 million new cases and 935,000 deaths in 2020, according to the World Health Organization. Patients with metastatic colorectal cancer typically undergo first-line treatment consisting of fluorouracil-based chemotherapy (oxaliplatin and irinotecan) with or without vascular endothelial growth factor (VEGF)-based therapy (primarily bevacizumab), and epidermal growth factor receptor (EGFR)-targeted therapies (in patients with RAS wild-type tumors). Second-line treatment options may include alternative chemotherapy regimens. Third-line treatment options are often limited for patients with metastatic colorectal cancer, as they tend to exhibit poor objective response rates and short progression-free survival. However, despite their good performance status, patients often encounter limited options for third-line treatment, resulting in a daunting and frustrating situation. This study will enroll patients aged ≥18 years who are resistant or intolerant to oxaliplatin and irinotecan-based chemotherapy. The study will evaluate the safety of the Nelmastobart and capecitabine combination therapy in Phase 1b. After identifying the Recommended Phase 2 Dose (RP2D), the study will assess the efficacy of the Nelmastobart and capecitabine combination therapy in Phase 2.