About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ADG126
- Pembrolizumab
Treatment groups
Sponsors and collaborators
National University Hospital, Singapore
Lead sponsor
Adagene Inc
Collaborator