Actively Recruiting
A Dose-expansion Trial Exploring the Safety and Efficacy of Intravenous HNF4 1 srRNA in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer
Led by Shanghai Changzheng Hospital · Updated on 2025-07-03
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and preliminary efficacy of intravenous CD-GA-102, a self-replicating RNA therapy, alone or combined with immunotherapy and other systemic treatments in patients with unresectable locally advanced or metastatic colorectal cancer. This early phase 1, single-arm, open-label trial builds on prior dose-escalation results to explore treatment effects in this patient population. CD-GA-102 will be given through peripheral intravenous injection at 50 micrograms per dose, with the second dose administered about 2 weeks after the first and the third dose about 4 weeks after the first. Following these initial doses, maintenance therapy will be given every 3 weeks, with dosing intervals adjusted based on individual safety and response. After at least two doses and safety evaluation, participants may receive combination treatment with immune checkpoint inhibitors, targeted therapy, or other systemic drugs as decided by the investigator. Participants will be monitored through clinical assessments, imaging, and laboratory tests over approximately 2 years to evaluate tumor response using RECIST v1.1 criteria and to observe safety and tolerability. Key measures include objective response rate, duration of response, progression-free survival, overall survival, disease control, and patient-reported outcomes. This study aims to provide detailed safety and early efficacy data for this novel treatment approach in colorectal cancer.
CONDITIONS
Brief Title
A Dose-Expansion Trial of Intravenous HNF4α srRNA for Unresectable or Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Diagnosis of colorectal cancer confirmed by histology or cytology
- Unresectable locally advanced or metastatic colorectal cancer
- Not suitable for or intolerant of standard systemic therapy, or progressed after standard therapy including chemotherapy and targeted drugs
- At least one measurable lesion per RECIST v1.1, excluding lesions treated locally unless clearly progressed
- Life expectancy of at least 12 weeks
- ECOG Performance Status score of 0 to 2
- Fertile males and women of childbearing potential agree to effective contraception until 6 months after last dose; women must have a negative pregnancy test within 7 days before first dose
- Willing to sign informed consent and comply with study protocol
You will not qualify if you...
- Completed standard adjuvant chemotherapy after tumor resection and relapsed/metastasized after 6 months drug-free interval without further systemic therapy
- Mismatch repair deficiency or high microsatellite instability tumors without prior immune checkpoint inhibitor treatment
- Current intestinal obstruction, perforation, bleeding, or high risk of these conditions
- Low serum albumin (<28 g/L) or elevated bilirubin, AST, ALP, or ALT beyond specified limits
- Significant kidney impairment or elevated creatinine levels
- Low blood counts (neutrophils, platelets, hemoglobin) or high INR (>2)
- Known brain metastases
- Uncontrolled hypertension, diabetes, severe heart or lung disease, or severe organ dysfunction
- Recent anti-tumor treatments within 4 weeks or radiotherapy within 3 weeks, except for progression
- Ongoing significant adverse events from prior treatments (Grade 2 or higher)
- Active infections or malignancies other than colorectal cancer within 5 years except low-risk cancers
- Active autoimmune diseases requiring recent or planned systemic therapy
- Need for systemic corticosteroids or immunosuppressants before study drug
- History of allogeneic organ or stem cell transplant
- Positive for HBV-DNA, HCV RNA, or HIV
- Known active tuberculosis
- Pregnant or breastfeeding women or those who cannot rule out pregnancy
- Participation in other drug trials within past 4 weeks
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation, with dosing every 2 to 3 weeks initially and maintenance dosing every 3 weeks thereafter
Participants receive intravenous CD-GA-102 at 50 μg per dose. The second dose is given approximately 2 weeks after the first, the third dose approximately 4 weeks after the first, followed by maintenance doses every 3 weeks. Dosing intervals may be adjusted based on tolerability and safety. After at least two doses and safety assessment, participants may receive combination therapies as determined by the investigator.
Multiple visits corresponding to each dosing, approximately every 2 to 3 weeks
Duration - Up to 24 months after treatment
Participants are monitored for safety, treatment response, and long-term outcomes after treatment completion or discontinuation.
Follow-up visits scheduled as per study protocol up to 24 months
Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital
Shanghai, None Selected, China, 200003
Actively Recruiting
Research Team
W
Wen-Ping Xu, MD. PhD
W
Weifen Xie, MD. PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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