NCT06846268

Neoadjuvant ADG126 and Pembrolizumab in Locally Advanced Colorectal Cancer

Phase II Trial of Neoadjuvant ADG126 and Pembrolizumab in Locally Advanced Colorectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This clinical trial aims to enrol patients with stage II or III colorectal cancer. At least 16, and up to 20 patients will be recruited. Patients will be given two cycles of neoadjuvant immunotherapy (ADG 126 and pembrolizumab). They will be assessed for response at 4 weeks or if they develop clinical symptoms of progression. Patients will undergo surgery 2 weeks (± 1 week) after the second dose of study treatment and within 8 weeks of study enrolment.

Conditions

• Locally Advanced Colorectal Cancer

Interventions

Type	Name	Description
DRUG	ADG126	Administered via intravenous infusion on Day 1 only (Q6W) or Day 1 and Day 22 (Q3W).
DRUG	Pembrolizumab	Administered via intravenous infusion on Day 1 and Day 22.

Timeline

• Start date: 2025-04-14
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-02-26
• Last updated: 2025-07-25

Locations

1 site across 1 country: Singapore