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Tests treatment safety and results for Metastatic Colorectal Cancer (mCRC)
Official title A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α SrRNA in Treating Metastatic CRC Patients
ClinicalTrials.gov ID: NCT06621173
What this study is testing
What is HNF4α srRNA?
HNF4α srRNA is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic colorectal cancer (mcrc).
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 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.
- 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
- 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 people who are unsuitable or unable to tolerate standard systemic therapy, or who have received standard systemic therapy but have...
- Patients with confirmed deficient mismatch repair (dMMR) or high microsatellite instability (MSI-H) in tumor tissue, who have been treated with...
- According to the RECIST (version 1.1) criteria, there are measurable target lesions suitable for repeated measurements for assessment.
You likely can't join if
- Patients with any of the following criteria were excluded from participation in this study
- Patients who have undergone standard adjuvant chemotherapy after tumor resection, and have experienced recurrence or metastasis within 6 months after...
- Clinical or imaging indications suggest the current presence of intestinal obstruction, perforation, or bleeding; or those who, upon investigator...
- Inadequate liver function：serum bilirubin \> 3 × the upper limit of normal (ULN), or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or...
- Inadequate renal function defined as creatinine \>1.5 × ULN or calculated creatinine clearance \< 40 mL/min.
- Absolute neutrophil count (ANC) \< 1.5×109/L, or Platelets \< 50×109/L, or Hemoglobin \< 9.0 g/dL.
See the full eligibility criteria
- 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 people 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...
- 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...
- 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.
- people 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...
- people who had a voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
- Patients with any of the following criteria were excluded from participation in this study
- Patients who have undergone standard adjuvant chemotherapy after tumor resection, and have experienced recurrence or metastasis within 6 months after discontinuing the medication, and have not received standard systemic...
- Clinical or imaging indications suggest the current presence of intestinal obstruction, perforation, or bleeding; or those who, upon investigator assessment, are at a higher risk of perforation or bleeding.
- Inadequate liver function：serum bilirubin \> 3 × the upper limit of normal (ULN), or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or alanine aminotransferase (ALT) \> 5 × ULN.
- Inadequate renal function defined as creatinine \>1.5 × ULN or calculated creatinine clearance \< 40 mL/min.
- Absolute neutrophil count (ANC) \< 1.5×109/L, or Platelets \< 50×109/L, or Hemoglobin \< 9.0 g/dL.
- International normalized ratio (INR) \> 2.0.
- Patients with confirmed tumor brain metastases.
- Poorly controlled hypertension, diabetes or other serious heart or lung diseases, or with serious dysfunction.
- Patients who have received local or systemic anti-tumor treatments such as immunotherapy, targeted therapy, and chemotherapy within 4 weeks, or radiation therapy within 3 weeks, except for treatment regimens assessed as...
- All toxicities related to prior locoregional or systemic anti-tumor treatments are still grade 2 or more (except for hair loss and other events that have been judged tolerable by researchers).
- Uncontrolled active infection (eg, lung infections, or abdominal infections).
- History of malignancy other than CRC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival rate \> 90%), such as adequately...
- Having an active autoimmune disease that requires systemic treatment within the past 2 years.
- Any condition requiring systemic treatment with corticosteroids (prednisone or equivalent \>10mg/day) or other immunosuppressive drugs within 14 days prior to the first administration of the investigational drug.
- Patients with a history of organ transplantation.
- Hepatitis B virus DNA greater than 500 IU/ml, or hepatitis C virus RNA greater than 100 IU/ml.
- Positive for human immunodeficiency virus (HIV).
- Pregnant/lactating women, or women with the possibility of pregnancy.
- Individuals who have participated in other drug trials within 4 weeks.
- Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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, Shanghai Municipality, 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.