Phase I-II Study of PD1 AB122 and Adenosine Receptor AB928 Antagonists with Chemotherapy After Short-Course Radiation for Rectal Cancer

What this Trial Is About

This research aims to evaluate the safety and effectiveness of combining PD1 antagonist AB122 and adenosine receptor antagonist AB928 with chemotherapy after short-course radiation therapy for patients with rectal cancer. The study is a Phase II trial conducted by Weill Medical College of Cornell University, focusing on patients who have a confirmed diagnosis of rectal adenocarcinoma and are eligible for total mesorectal excision surgery. Participants will receive a short-course radiotherapy treatment delivering 25 Gy in 5 fractions during the first week, alongside oral AB928 taken once daily at 150 mg continuously. Following radiation, from weeks 3 to 20, participants will undergo consolidation chemotherapy with nine cycles of the mFOLFOX regimen combined with AB928 and AB122. After this treatment phase, patients will be assessed between weeks 22 and 24 using digital rectal examination, pelvic MRI, and endoscopy. Based on these evaluations, patients will proceed to total mesorectal excision surgery for further pathological assessment. Throughout the study, patients will be monitored for therapeutic response and safety, including treatment-related adverse events at multiple time points. The primary outcome is the number of patients achieving complete pathologic response at week 24. Secondary measures include adverse event frequency, progression-free survival at 36 months, and overall survival at 60 months. The total study duration extends until December 2031, with careful review by a multidisciplinary tumor board to guide treatment decisions.

A Phase I-II Study to Test the Safety and Efficacy of PD1 (AB122) and Adenosine Receptor (AB928) Antagonists With Chemotherapy After Short-Course Radiation for Rectal Cancer.