This is a single site, open-label, single-arm phase II study to determine feasibility, tolerability, and preliminary efficacy of neoadjuvant ADG126 and pembrolizumab in stage II or III colorectal cancer.
Willing and able to provide written informed consent for the trial.
Be ≥ 21 years of age on the date of signing informed consent.
ECOG performance status of 0 or 1.
Histologically confirmed colorectal adenocarcinoma. Rectal cancers allowed if the treatment plan was upfront surgery with no need for any neoadjuvant chemotherapy or radiation.
Recurrent colorectal cancer.
Prior radiation therapy, chemotherapy, immunotherapy, or surgery for colorectal cancer.
Tumour is causing symptomatic bowel obstruction (patients who have a temporary diverting stoma are eligible).
Other invasive malignancy ≤5 years prior to registration.
Sequential
ADG126
DrugAdministered via intravenous infusion on Day 1 only (Q6W) or Day 1 and Day 22 (Q3W).
Pembrolizumab
DrugAdministered via intravenous infusion on Day 1 and Day 22.
Rate of Major Pathologic Response (MPR)
MPR is defined as less than or equal to 10% of residual viable tumour in the surgical specimen.
Rate of Pathologic Complete Response (pCR)
pCR is defined as the absence of any residual viable tumour in the surgical specimen.
Objective Response Rate (ORR)
Determined by the investigator according to RECIST 1.1 criteria.
Disease-free survival (DFS)
DFS is defined as the time from surgery to the first occurrence of disease relapse or death from any cause.
Adverse Events and Serious Adverse Events
Graded using NCI CTCAE toxicity grading v5.0
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National University Hospital, Singapore
Lead sponsor
Adagene Inc
Collaborator
