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New treatment option for Colorectal Cancer Metastatic
Official title A Dose-Expansion Trial of Intravenous HNF4α srRNA for Unresectable or Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT07050394
What this study is testing
What is CD-GA-102?
CD-GA-102 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years, regardless of gender.
- Patients with colorectal cancer confirmed by histology or cytology.
- Patients with unresectable locally advanced or metastatic colorectal cancer.
- Patients who are not suitable for or intolerant of standard systemic therapy; or patients who have progressed after receiving standard systemic...
- According to RECIST v1.1, patients must have at least one measurable lesion. Lesions that have received local treatment (including surgery...
You likely can't join if
- Patients who have completed standard adjuvant chemotherapy after tumor resection and relapsed or developed metastasis after a drug-free interval of 6...
- Patients with tumor tissue testing confirming mismatch repair deficiency or high microsatellite instability (dMMR/MSI-H) who have not received immune...
- Patients with clinical or radiological evidence of current intestinal obstruction, perforation, or bleeding; or patients assessed by the investigator...
- Serum albumin \ 3×ULN, or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or alanine aminotransferase (ALT) \> 5×ULN.
- Patients with significant renal impairment, serum creatinine \> 1.5×ULN, or creatinine clearance \< 40 mL/min; urine protein \<2+ (if urine protein...
- Absolute neutrophil count \< 1.5×10\^9/L, or platelets \< 50×10\^9/L, or hemoglobin \< 9 g/dL.
See the full eligibility criteria
Who can join
- Age ≥ 18 years, regardless of gender.
- Patients with colorectal cancer confirmed by histology or cytology.
- Patients with unresectable locally advanced or metastatic colorectal cancer.
- 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...
- 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...
- Life expectancy ≥ 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.
- 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...
- Willing to sign the written informed consent form and voluntarily comply with the protocol.
What rules you out
- 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.
- 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...
- 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.
- Serum albumin \ 3×ULN, or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or alanine aminotransferase (ALT) \> 5×ULN.
- 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...
- Absolute neutrophil count \< 1.5×10\^9/L, or platelets \< 50×10\^9/L, or hemoglobin \< 9 g/dL.
- International Normalized Ratio (INR) \> 2.
- Patients with known brain metastases from tumors.
- Patients with uncontrolled hypertension, diabetes, or other severe cardiac or pulmonary diseases, or severe organ dysfunction.
- 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...
- 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).
- Patients with uncontrollable active infections (e.g., pulmonary or abdominal infections).
- 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...
- 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...
- 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.
- Patients who are preparing for or have previously undergone allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Patients who are positive for HBV-DNA or HCV RNA.
- 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.
- Patients who are positive for human immunodeficiency virus (HIV).
- Pregnant or breastfeeding women, or women who cannot rule out the possibility of pregnancy.
- Patients who have participated in other drug trials within the past 4 weeks.
- Other situations deemed by the investigator as unsuitable for participation in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, None Selected, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, None Selected, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.