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

Launched by SHANGHAI CHANGZHENG HOSPITAL · Jun 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CD-GA-102, given through a vein, for people with advanced colorectal cancer that cannot be removed by surgery or has spread to other parts of the body. The main goals are to see if this treatment is safe and well-tolerated, either by itself or combined with other therapies like immunotherapy. The study also wants to explore early signs of whether the treatment might help control the cancer.

People who may be eligible for this trial are adults with confirmed colorectal cancer that is advanced or metastatic and who have either not responded to standard treatments or cannot take them due to side effects. Participants need to have measurable tumors and be in generally good health with a life expectancy of at least 12 weeks. During the study, participants will receive the study drug through an IV and will be closely monitored for side effects and how their cancer responds. It’s important to note that this trial is still recruiting patients, and not everyone will qualify due to specific health conditions or prior treatments. If you or a loved one are considering this trial, the research team will provide detailed information and support throughout the process.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years, regardless of gender.
• • 2. Patients with colorectal cancer confirmed by histology or cytology.
• • 3. Patients with unresectable locally advanced or metastatic colorectal cancer.
• • 4. Patients who are not suitable for or intolerant of standard systemic therapy; or patients who have progressed after receiving standard systemic therapy (including but not limited to the following regimens) as confirmed by RECIST v1.1: chemotherapy based on fluorouracil, oxaliplatin, or irinotecan, and targeted drugs such as anti-VEGF/EGFR monoclonal antibodies.
• • 5. According to RECIST v1.1, patients must have at least one measurable lesion. Lesions that have received local treatment (including surgery, radiotherapy, TACE, and ablation) cannot be selected as target lesions, unless the lesion is the only measurable lesion and has clearly progressed according to imaging, in which case it may be considered as a target lesion.
• • 6. Life expectancy ≥ 12 weeks.
• • 7. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.
• • 8. Fertile male participants and women of childbearing age must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose of the investigational drug. Women of childbearing age include premenopausal women and women within 2 years of menopause. Women of childbearing age must have a negative serum pregnancy test within ≤7 days before the first dose of the investigational drug.
• • 9. Willing to sign the written informed consent form and voluntarily comply with the protocol.
• Exclusion Criteria:
• • 1. Patients who have completed standard adjuvant chemotherapy after tumor resection and relapsed or developed metastasis after a drug-free interval of 6 months, and have not received standard systemic therapy.
• • 2. Patients with tumor tissue testing confirming mismatch repair deficiency or high microsatellite instability (dMMR/MSI-H) who have not received immune checkpoint inhibitor treatment (PD-1 monoclonal antibody or PD-L1 monoclonal antibody).
• • 3. Patients with clinical or radiological evidence of current intestinal obstruction, perforation, or bleeding; or patients assessed by the investigator to be at high risk of perforation or bleeding.
• • 4. Serum albumin \< 28 g/L, or bilirubin \> 3×ULN, or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or alanine aminotransferase (ALT) \> 5×ULN.
• • 5. Patients with significant renal impairment, serum creatinine \> 1.5×ULN, or creatinine clearance \< 40 mL/min; urine protein \<2+ (if urine protein ≥2+, a 24-hour urine protein quantification is required, and patients with 24-hour urine protein quantification \<1 g may be eligible).
• • 6. Absolute neutrophil count \< 1.5×10\^9/L, or platelets \< 50×10\^9/L, or hemoglobin \< 9 g/dL.
• • 7. International Normalized Ratio (INR) \> 2.
• • 8. Patients with known brain metastases from tumors.
• • 9. Patients with uncontrolled hypertension, diabetes, or other severe cardiac or pulmonary diseases, or severe organ dysfunction.
• • 10. Patients who have received local or systemic anti-tumor treatments (including immunotherapy, targeted therapy, or chemotherapy) within 4 weeks, or radiotherapy within 3 weeks, except for treatment regimens assessed as disease progression according to RECIST (version 1.1) criteria.
• • 11. Patients with adverse events related to previous local or systemic anti-tumor treatments still ≥ Grade 2 (excluding alopecia and other events deemed tolerable by the investigator).
• • 12. Patients with uncontrollable active infections (e.g., pulmonary or abdominal infections).
• • 13. Patients with malignancies other than colorectal cancer within the past 5 years, with the exception of low-risk malignancies with a low risk of metastasis or death (estimated 5-year overall survival \> 90%), such as early gastrointestinal cancer treated effectively, cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, etc.
• • 14. Patients with active autoimmune diseases requiring systemic therapy within the past 2 years, or autoimmune diseases judged by the investigator to have a potential for recurrence or planned treatment, including but not limited to inflammatory bowel disease, celiac disease, Wegener's granulomatosis, Hashimoto's thyroiditis, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis.
• • 15. Patients who require systemic treatment with corticosteroids (prednisone or equivalent \> 10 mg/day) or other immunosuppressive drugs within 14 days before the first dose of the investigational drug.
• • 16. Patients who are preparing for or have previously undergone allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• • 17. Patients who are positive for HBV-DNA or HCV RNA.
• • 18. Patients with known active tuberculosis. Patients suspected of having active tuberculosis must be excluded based on chest imaging, sputum tests, and clinical symptoms and signs.
• • 19. Patients who are positive for human immunodeficiency virus (HIV).
• • 20. Pregnant or breastfeeding women, or women who cannot rule out the possibility of pregnancy.
• • 21. Patients who have participated in other drug trials within the past 4 weeks.
• • 22. Other situations deemed by the investigator as unsuitable for participation in this clinical trial.