Colorectal Cancer MetastaticEarly Phase 1NCT07050394
A Dose-Expansion Trial of Intravenous HNF4α srRNA for Unresectable or Metastatic Colorectal Cancer
A Early Phase 1 study testing CD-GA-102 in people with Colorectal Cancer Metastatic and Colorectal Cancer Recurrent, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic, Colorectal Cancer Recurrent, Colorectal Cancer Stage IV
- What is being tested?
- CD-GA-102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2025to Jun 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 by RECIST v1.1: chemotherapy based on fluorouracil, oxaliplatin, or irinotecan, and targeted drugs such as anti-VEGF/EGFR monoclonal antibodies.
- 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 the lesion is the only measurable lesion and has clearly progressed according to imaging, in which case it may be considered as a target lesion.
- Life expectancy ≥ 12 weeks.
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- 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 of childbearing age include premenopausal women and women within 2 years of menopause. Women of childbearing age must have a negative serum pregnancy test within ≤7 days before the first dose of the investigational drug.
- Willing to sign the written informed consent form and voluntarily comply with the protocol.
Who cannot join
- 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.
- 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 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.
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- 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 disease progression according to RECIST (version 1.1) criteria.
- 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 early gastrointestinal cancer treated effectively, cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, etc.
- 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 limited to inflammatory bowel disease, celiac disease, Wegener's granulomatosis, Hashimoto's thyroiditis, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, None Selected, 200003
Wen-Ping Xu, MD. PhD, +862115026590980, xwp198527@sina.com
Weifen Xie, MD. PhD, +862113701682806, weifenxie@medmail.com.cn
About this study
Official title: A Dose-expansion Trial Exploring the Safety and Efficacy of Intravenous HNF4α srRNA in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer
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.
Read the detailed description
In this study, CD-GA-102 will be administered via peripheral intravenous injection for the treatment of colorectal cancer at a dose of 50 μg per administration. The second dose will be given 2 weeks (±3 days) after the initial administration, and the third dose will be given 4 weeks (±3 days) after the initial administration. Subsequently, maintenance therapy will be administered every 3 weeks (±3 days). The dosing interval may be adjusted based on the participants' tolerability, safety, and therapeutic response. After receiving at least two doses of intravenous monotherapy with CD-GA-102 and completing the safety assessment following the last dose, participants may be offered combination therapy with immune checkpoint inhibitors, targeted therapy, or other systemic treatments, as determined by the investigator after a comprehensive evaluation.
Up to approximately 20 participants will be enrolled in this dose-expansion phase. Based on the results of this phase, the safety and tolerability of intravenous monotherapy with CD-GA-102 or its combination with immunotherapy and other systemic treatments will be further assessed. The antitumor activity will be evaluated according to the RECIST v1.1 criteria.
- Being tested
- CD-GA-102
- Keywords
- Colorectal Cancer, Hepatocyte nuclear factor 4α, Differentiation therapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD-GA-102Drug
CD-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.
| Study group | Role | What they receive |
|---|---|---|
| CD-GA-102 | Experimental | A lipid nanoparticle-encapsulated self-replicating RNA encoding hepatocyte nuclear factor 4α Receives: Drug: CD-GA-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the first study dose date until the date of documented complete response or partial response, assessed up to 24 months
Secondary outcomes (12)
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
Measured: Through study completion, an average of 2 years
Duration of Response (DOR)
Duration of Response (DOR) evaluated according to RECIST v1.1 criteria
Measured: up to 24 months
Progression-Free Survival，PFS
Progression-Free Survival of patients evaluated according to RECIST v1.1 criteria
Measured: up to 24 months
Time To Progression，TTP
Time To Progression of patients evaluated according to RECIST v1.1 criteria
Measured: up to 24 months
Time To Response，TTR
Time To Response of patients evaluated according to RECIST v1.1 criteria
Measured: up to 24 months
Disease Control Rate，DCR
Disease Control Rate evaluated according to RECIST v1.1 criteria
Measured: up to 24 months
Clinical Benefit Rate，CBR
Clinical Benefit Rate evaluated according to RECIST v1.1 criteria
Measured: up to 24 months
Overall Survival，OS
Overall Survival of patients
Measured: Throughout the entire course of treatment until the end of the follow-up period, an average of 2 years
Patient Reported Outcome-1，PRO-1
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
Measured: Through study completion, an average of 2 years
Patient Reported Outcome-2，PRO-2
Functional Assessment of Cancer Therapy Colorectal Cancer (FACT-C)
Measured: Through study completion, an average of 2 years
Patient Reported Outcome-3，PRO-3
The Generic EuroQol Five Dimension Five Level (EQ-5D-5L) Questionnaire
Measured: Through study completion, an average of 2 years
Changes in tumor markers
Changes in tumor markers such as Carcinoembryonic Antigen (CEA) and Carbohydrate Antigen 199 (CA199) after treatment.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start10 Jun 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-Fen Xie, Shanghai Changzheng Hospital
- Investigators
- Weifen Xie, MD. PhD, Principal investigator, Naval Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050394
- Sponsor's protocol ID
- CZXH-CRC-2025-IIT
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-expansion Trial Exploring the Safety and Efficacy of Intravenous HNF4α srRNA in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07050394
- Acronym / sponsor ID
- CZXH-CRC-2025-IIT
- Keywords
- Colorectal Cancer, Hepatocyte nuclear factor 4α, Differentiation therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study, CD-GA-102 will be administered via peripheral intravenous injection for the treatment of colorectal cancer at a dose of 50 μg per administration. The second dose will be given 2 weeks (±3 days) after the initial administration, and the third dose will be given 4 weeks (±3 days) after the initial administration. Subsequently, maintenance therapy will be administered every 3 weeks (±3 days). The dosing interval may be adjusted based on the participants' tolerability, safety, and therapeutic response. After receiving at least two doses of intravenous monotherapy with CD-GA-102 and completing the safety assessment following the last dose, participants may be offered combination therapy with immune checkpoint inhibitors, targeted therapy, or other systemic treatments, as determined by the investigator after a comprehensive evaluation.
Up to approximately 20 participants will be enrolled in this dose-expansion phase. Based on the results of this phase, the safety and tolerability of intravenous monotherapy with CD-GA-102 or its combination with immunotherapy and other systemic treatments will be further assessed. The antitumor activity will be evaluated according to the RECIST v1.1 criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD-GA-102 | Experimental | Drug: CD-GA-102A lipid nanoparticle-encapsulated self-replicating RNA encoding hepatocyte nuclear factor 4α |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- 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 the lesion is the only measurable lesion and has clearly progressed according to imaging, in which case it may be considered as a target lesion.
Key exclusion criteria (22 listed)
- 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.
- 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 with 24-hour urine protein quantification <1 g may be eligible).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD-GA-102CD-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. | Drug | CD-GA-102 |
Primary outcome
Objective Response Rate，ORR
Time frame: From the first study dose date until the date of documented complete response or partial response, assessed up to 24 months
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
12 secondary outcomes
Safty and tolerability
Time frame: Through study completion, an average of 2 years
Duration of Response (DOR)
Time frame: up to 24 months
Progression-Free Survival，PFS
Time frame: up to 24 months
Time To Progression，TTP
Time frame: up to 24 months
Time To Response，TTR
Time frame: up to 24 months
Disease Control Rate，DCR
Time frame: up to 24 months
Clinical Benefit Rate，CBR
Time frame: up to 24 months
Overall Survival，OS
Time frame: Throughout the entire course of treatment until the end of the follow-up period, an average of 2 years
Patient Reported Outcome-1，PRO-1
Time frame: Through study completion, an average of 2 years
Patient Reported Outcome-2，PRO-2
Time frame: Through study completion, an average of 2 years
Patient Reported Outcome-3，PRO-3
Time frame: Through study completion, an average of 2 years
Changes in tumor markers
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Weifen Xie, MD. PhD principal investigator
Naval Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CD-GA-102 in people with Colorectal Cancer Metastatic and Colorectal Cancer Recurrent, run by Shanghai Changzheng Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wen-Ping Xu, MD. PhD (+862115026590980, xwp198527@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate，ORR (time frame: From the first study dose date until the date of documented complete response or partial response, assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.