This study aims to evaluate the efficacy and safety of the concurrent combination therapy of S 531011 + fruquintinib or S 531011 + fruquintinib + pembrolizumab in patients with MSS/pMMR colorectal cancer.
Patients with histologically confirmed unresectable adenocarcinoma of the colon or rectum.
Confirmed microsatellite stable (MSS) or proficient mismatch repair (pMMR) status.
Presence of measurable disease according to RECIST version 1.1.
Age ≥ 18 years at the time of informed consent.
Prior treatment with fruquintinib for metastatic colorectal cancer.
Prior treatment with any anti-CCR8 antibody, regardless of indication.
Receipt of chemotherapy, radiotherapy, immunotherapy, or any antitumor therapy, or investigational agents within 14 days prior to enrollment, or persistence of CTCAE Grade ≥ 2 toxicities from prior therapies (excluding alopecia, hyperpigmentation, and peripheral sensory neuropathy).
History of acute coronary syndrome (including myocardial infarction or unstable angina), coronary angioplasty, or stent placement within 6 months prior to enrollment.
National Cancer Center Hospital East
Lead sponsor
Shionogi
Collaborator