A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer

Korábbi kezelés

• Prior treatment with immunotherapy, including immune checkpoint inhibitors , immune checkpoint agonists, immune cell therapy and any treatment targeting tumor immune pathway
• Prior allogeneic stem cell or solid organ transplantation
• Receipt of a live, attenuated vaccine within 30 days prior to randomization, during treatment

Más betegség

• History of autoimmune disease
• Positive test for human immunodeficiency virus,Active hepatitis B or hepatitis C

Egyéb

• Known MSI-H(Microsatellite-Instability-High) or dMMR(Mismatch Repair-Deficient)
• Pregnancy or lactation
• Dysphagia

• Histologically proven diagnosis of colorectal adenocarcinoma
• Part1: Subjects who have not previously received any systemic antitumor therapy and who have previously received neoadjuvant or adjuvant therapy, the first detection of recurrence or metastasis should be ≥12 months after the last administration of neoadjuvant or adjuvant therapy
• Part2: Subjects who have previously received systemic therapy including fluorouracil, oxaliplatin, irinotecan, bevacizumab or anti-EGFR antibodies or could not tolerate or have contraindications to standard treatment
• Eastern Cooperative Oncology Group performance status of 0 or 1
• Measurable disease as defined by RECIST v1.1
• Adequate hematologic and organ function