A Clinical Trial Assessing the Safety and Efficacy of Intravenous HNF4α SrRNA for the Treatment of Patients With Metastatic Colorectal Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

This trial is a single-arm, open-label, exploratory first-in-human clinical study designed to evaluate the safety and tolerability of HNF4α srRNA injection in patients with locally unresectable or metastatic colorectal cancer, and to preliminarily explore its effectiveness in treating metastatic colorectal cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Males or females, aged 18 years or older.

• Patients with histologically confirmed colorectal cancer that has been determined to be unresectable or metastatic.

• Colorectal cancer subjects who are unsuitable or unable to tolerate standard systemic therapy, or who have received standard systemic therapy but have disease progression based on RECIST (version 1.1) criteria, including chemotherapy based on fluorouracil, oxaliplatin, or irinotecan, and targeted therapies with anti-VEGF/EGFR monoclonal antibodies.

• Patients with confirmed deficient mismatch repair (dMMR) or high microsatellite instability (MSI-H) in tumor tissue, who have been treated with immune checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) and are assessed with disease progression.

• According to the RECIST (version 1.1) criteria, there are measurable target lesions suitable for repeated measurements for assessment.

• Life expectancy of 12 weeks or more.

• Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2.

• Males with fertility and females of childbearing potential are willing to use a highly effective method of contraception for the entire study period and for 6 months after study drug discontinuation. Females of childbearing age, including premenopausal females and within 2 years after menopause, must have a negative serum pregnancy test result within 7 days prior to the first dose of study treatment.

• Subjects who had a voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.

Locations
Other Locations
China
Shanghai Changzheng Hospital,Naval Medical University
RECRUITING
Shanghai
Contact Information
Primary
Beifang Ning, MD. PhD
ningbeifang@163.com
13764001892
Backup
Weifen Xie, MD. PhD
weifenxie@medmail.com.cn
13701682806
Time Frame
Start Date: 2024-11-12
Estimated Completion Date: 2026-09
Participants
Target number of participants: 9
Treatments
Experimental: HNF4α srRNA treatment
The subjects with metastatic colorectal cancer will be treated by HNF4α srRNA intravenously via a peripheral vein.~According to Amendment 1, the HNF4α srRNA preparation CD-801 used in the original protocol will expire on December 31, 2024. For participants receiving treatment after this date, the preparation will be switched to CD-GA-102, with the treatment dose converted on a 1:1 basis.
Sponsors
Leads: Shanghai Changzheng Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials