NCT07050394

A Dose-Expansion Trial of Intravenous HNF4α srRNA for Unresectable or Metastatic Colorectal Cancer

A Dose-expansion Trial Exploring the Safety and Efficacy of Intravenous HNF4α srRNA in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, open-label, exploratory clinical trial. Building on the previous dose-escalation trial, this dose-expansion trial aims to evaluate the safety and tolerability of intravenous monotherapy with CD-GA-102 or its combination with immunotherapy and other systemic treatments in patients with unresectable locally advanced or metastatic colorectal cancer, and to preliminarily explore its efficacy in treating colorectal cancer.

Detailed description

In this study, CD-GA-102 will be administered via peripheral intravenous injection for the treatment of colorectal cancer at a dose of 50 μg per administration. The second dose will be given 2 weeks (±3 days) after the initial administration, and the third dose will be given 4 weeks (±3 days) after the initial administration. Subsequently, maintenance therapy will be administered every 3 weeks (±3 days). The dosing interval may be adjusted based on the participants' tolerability, safety, and therapeutic response. After receiving at least two doses of intravenous monotherapy with CD-GA-102 and completing the safety assessment following the last dose, participants may be offered combination therapy with immune checkpoint inhibitors, targeted therapy, or other systemic treatments, as determined by the investigator after a comprehensive evaluation. Up to approximately 20 participants will be enrolled in this dose-expansion phase. Based on the results of this phase, the safety and tolerability of intravenous monotherapy with CD-GA-102 or its combination with immunotherapy and other systemic treatments will be further assessed. The antitumor activity will be evaluated according to the RECIST v1.1 criteria.

Conditions

• Colorectal Cancer Metastatic
• Colorectal Cancer Recurrent
• Colorectal Cancer Stage IV

Interventions

Type	Name	Description
DRUG	CD-GA-102	CD-GA-102 will be administered intravenously at 50 μg per dose, with dosing scheduled at 2 weeks (±3 days) and 4 weeks (±3 days) after the initial dose, followed by maintenance therapy every 3 weeks (±3 days). Dosing intervals may be adjusted based on participant tolerability and safety. After receiving at least two doses of CD-GA-102 monotherapy and completing safety assessments, participants may be offered combination therapies, as determined by the investigator.

Timeline

• Start date: 2025-06-10
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2025-07-03
• Last updated: 2025-07-03

Locations

1 site across 1 country: China