Actively Recruiting
Neoadjuvant ADG126 and Pembrolizumab in Locally Advanced Colorectal Cancer
Led by National University Hospital, Singapore · Updated on 2025-07-25
20
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
Sponsors
N
National University Hospital, Singapore
Lead Sponsor
A
Adagene Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant ADG126 and Pembrolizumab in Locally Advanced Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent for the trial.
- Be 21 years of age or older at the time of signing informed consent.
- Have an ECOG performance status of 0 or 1.
- Have histologically confirmed colorectal adenocarcinoma, including rectal cancers planned for upfront surgery with no neoadjuvant chemotherapy or radiation.
- Clinical stage II (T3-4, N-) or stage III (Tany, N+).
- No evidence of distant metastases.
- Have radiologically measurable or clinically evaluable disease.
- For women of childbearing potential, have a negative pregnancy test within 72 hours before registration.
- Willing to use adequate contraception during the study and for 150 days after the last dose if of childbearing potential.
- Demonstrate adequate organ function including specified blood counts, renal, hepatic, and coagulation parameters within 28 days before treatment.
You will not qualify if you...
- Recurrent colorectal cancer.
- Prior radiation therapy, chemotherapy, immunotherapy, or surgery for colorectal cancer.
- Tumor causing symptomatic bowel obstruction (except those with a temporary diverting stoma).
- Other invasive malignancy within 5 years prior to registration.
- Immunodeficiency or use of systemic steroids or immunosuppressive therapy within 7 days before first trial treatment.
- Active autoimmune disease requiring systemic treatment within past 2 years or history of severe autoimmune disease.
- Active infection requiring systemic therapy.
- Prior therapy targeting T-cell co-stimulation or checkpoint pathways.
- History of grade 3 or higher immune-related adverse events with prior immunotherapy, except non-clinically significant lab abnormalities.
- Use of other anticancer or experimental therapies while receiving study treatment.
- Known HIV infection.
- Active hepatitis B or C infection.
- Pregnancy, breastfeeding, or men planning to father children during the study period.
- Concurrent medical or psychiatric conditions making the patient unsuitable for the study.
- Receipt of live vaccine within 30 days before starting study medication.
- Major surgery, open biopsy, or significant injury within 28 days before enrollment.
- History of interstitial lung disease.
- Known hypersensitivity to ADG126 or pembrolizumab components or excipients.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National University Hospital
Singapore, Singapore, 119074
Actively Recruiting
Research Team
W
Wei Peng Yong, MD
CONTACT
S
Silvana Wijaya, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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