OncoMatch/Clinical Trials/NCT07050394
A Dose-Expansion Trial of Intravenous HNF4α srRNA for Unresectable or Metastatic Colorectal Cancer
Is NCT07050394 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies CD-GA-102 for colorectal cancer metastatic.
Treatment: CD-GA-102 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage III, IV
Metastatic disease required
Patients with unresectable locally advanced or metastatic colorectal cancer.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard systemic therapy (fluorouracil, oxaliplatin, irinotecan, anti-VEGF monoclonal antibody, anti-EGFR monoclonal antibody)
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.
Cannot have received: adjuvant chemotherapy only
Exception: relapsed or developed metastasis after a drug-free interval of 6 months, and have not received standard systemic therapy
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.
Cannot have received: immune checkpoint inhibitor (PD-1 monoclonal antibody, PD-L1 monoclonal antibody)
Exception: required for dMMR/MSI-H patients
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).
Cannot have received: local or systemic anti-tumor treatments (including immunotherapy, targeted therapy, or chemotherapy)
Exception: except for treatment regimens assessed as disease progression according to RECIST (version 1.1) criteria
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.
Lab requirements
Blood counts
Absolute neutrophil count < 1.5×10^9/L, or platelets < 50×10^9/L, or hemoglobin < 9 g/dL
Kidney function
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)
Liver function
Serum albumin < 28 g/L, or bilirubin > 3×ULN, or AST, ALP, or ALT > 5×ULN [excluded]
Serum albumin < 28 g/L, or bilirubin > 3×ULN, or AST, ALP, or ALT > 5×ULN. 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). Absolute neutrophil count < 1.5×10^9/L, or platelets < 50×10^9/L, or hemoglobin < 9 g/dL.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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