NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer

Selected Inclusion Criteria: * Histologically confirmed adenocarcinoma of the rectum. * Locally advanced disease (clinical stage II-III based on pelvic MRI) selected by a multidisciplinary team for treatment with neoadjuvant CRT (which may be followed by CNCT to comprise planned TNT). Patients with oligometastatic disease are permitted provided that the site-specific multidisciplinary team deems them suitable for radical treatment/chemoradiation. * Confirmed microsatellite stable (MSS)/proficient mismatch repair (pMMR) status. * Provide written informed consent to participate. * ECOG Performance Status 0 or 1. * Must not be pregnant or breastfeeding. * Patients who are sexually active (with either sex) must agree to comply with contraceptive requirements. * Adequate lung reserve, renal function, hepatic function, and bone marrow/hematological function assessed ≤ 10 days prior to first dose. Selected Exclusion Criteria: * Recurrent rectal cancer. * Distant metastatic disease not amenable to radical treatment/chemoradiation. * Other prior malignancy active within the previous 3 years, except for local or organ confined early-stage cancer that has been definitively treated with curative intent, does not require ongoing treatment, has no evidence of residual disease, and has a negligible risk of recurrence and is therefore unlikely to interfere with the primary and secondary endpoints of the trial, including response rate and safety. * Splenectomy (patients with prior partial …