OncoMatch/Clinical Trials/NCT06621173
A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α SrRNA in Treating Metastatic CRC Patients
Is NCT06621173 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies HNF4α srRNA for metastatic colorectal cancer (mcrc).
Treatment: HNF4α srRNA — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MSH2 deficient mismatch repair
confirmed deficient mismatch repair (dMMR) or high microsatellite instability (MSI-H) in tumor tissue
Required: MSH6 deficient mismatch repair
confirmed deficient mismatch repair (dMMR) or high microsatellite instability (MSI-H) in tumor tissue
Required: MLH1 deficient mismatch repair
confirmed deficient mismatch repair (dMMR) or high microsatellite instability (MSI-H) in tumor tissue
Required: PMS2 deficient mismatch repair
confirmed deficient mismatch repair (dMMR) or high microsatellite instability (MSI-H) in tumor tissue
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic chemotherapy (fluorouracil, oxaliplatin, irinotecan) — standard systemic therapy
have received standard systemic therapy but have disease progression based on RECIST (version 1.1) criteria, including chemotherapy based on fluorouracil, oxaliplatin, or irinotecan
Must have received: anti-VEGF therapy — targeted therapy
targeted therapies with anti-VEGF/EGFR monoclonal antibodies
Must have received: anti-EGFR therapy — targeted therapy
targeted therapies with anti-VEGF/EGFR monoclonal antibodies
Must have received: anti-PD-1 therapy — immune checkpoint inhibitor
treated with immune checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) and are assessed with disease progression
Must have received: anti-PD-L1 therapy — immune checkpoint inhibitor
treated with immune checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) and are assessed with disease progression
Cannot have received: systemic chemotherapy
Exception: adjuvant chemotherapy after tumor resection with recurrence/metastasis within 6 months and no standard systemic therapy
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 therapy
Cannot have received: immunotherapy
Exception: except for treatment regimens assessed as disease progression according to RECIST v1.1
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 disease progression according to RECIST v1.1
Cannot have received: targeted therapy
Exception: except for treatment regimens assessed as disease progression according to RECIST v1.1
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 disease progression according to RECIST v1.1
Cannot have received: chemotherapy
Exception: except for treatment regimens assessed as disease progression according to RECIST v1.1
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 disease progression according to RECIST v1.1
Cannot have received: radiation therapy
Exception: except for treatment regimens assessed as disease progression according to RECIST v1.1
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 disease progression according to RECIST v1.1
Lab requirements
Blood counts
anc < 1.5×10^9/l, or platelets < 50×10^9/l, or hemoglobin < 9.0 g/dl
Kidney function
creatinine >1.5 × uln or calculated creatinine clearance < 40 ml/min
Liver function
serum bilirubin > 3 × uln, or ast, alp, or alt > 5 × uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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