A Dose-Expansion Trial of Intravenous HNF4α srRNA for Unresectable or Metastatic Colorectal Cancer
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Changzheng Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 by RECIST v1.1: chemotherapy based on fluorouracil, oxaliplatin, or irinotecan, and targeted drugs such as anti-VEGF/EGFR monoclonal antibodies.
Disqualifiers
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 monoclonal antibody).
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 < 28 g/L, or bilirubin > 3×ULN, or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or alanine aminotransferase (ALT) > 5×ULN.
Trial design
Design model
Single group
Treatments tested in this trial
CD-GA-102
DrugCD-GA-102 will be administered intravenously at 50 μg per dose, with dosing scheduled at 2 weeks (±3 days) and 4 weeks (±3 days) after the initial dose, followed by maintenance therapy every 3 weeks (±3 days). Dosing intervals may be adjusted based on participant tolerability and safety. After receiving at least two doses of CD-GA-102 monotherapy and completing safety assessments, participants may be offered combination therapies, as determined by the investigator.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: CD-GA-102Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate，ORR
Evaluate the objective response rate of HNF4α srRNA monotherapy or in combination with immunotherapy and other systemic treatments in patients with metastatic colorectal cancer, according to the RECIST v1.1 criteria
Time frame
From the first study dose date until the date of documented complete response or partial response, assessed up to 24 monthsSecondary outcomes
1
Safty and tolerability
Evaluate the incidence and severity of adverse events (AEs), serious adverse events (SAEs), and AEs leading to treatment discontinuation associated with intravenous monotherapy of CD-GA-102 or its combination with immunotherapy and other systemic treatments
Time frame
Through study completion, an average of 2 years2
Duration of Response (DOR)
Duration of Response (DOR) evaluated according to RECIST v1.1 criteria
Time frame
up to 24 months3
Progression-Free Survival，PFS
Progression-Free Survival of patients evaluated according to RECIST v1.1 criteria
Time frame
up to 24 months4
Time To Progression，TTP
Time To Progression of patients evaluated according to RECIST v1.1 criteria
Time frame
up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov