Metastatic Colorectal Cancer (mCRC)Early Phase 1NCT06621173
A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α SrRNA in Treating Metastatic CRC Patients
A Early Phase 1 study testing HNF4α srRNA in people with Metastatic Colorectal Cancer (mCRC), run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer (mCRC)
- What is being tested?
- HNF4α srRNA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 12 Nov 2024to Sep 2026
- 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
- 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 subjects 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 chemotherapy based on fluorouracil, oxaliplatin, or irinotecan, and targeted therapies with anti-VEGF/EGFR monoclonal antibodies.
- 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 assessed with disease progression.
- 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.
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- Subjects 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 childbearing age, including premenopausal females and within 2 years after menopause, must have a negative serum pregnancy test result within 7 days prior to the first dose of study treatment.
- Subjects who had a voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
Who cannot join
- 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 therapy.
- 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.
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- 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 disease progression according to RECIST v1.1.
- 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 treated early gastric carcinoma, carcinoma in situ of the cervix, non-melanoma skin carcinoma, or localized prostate cancer.
- 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.
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，Naval Medical University
Shanghai, Shanghai Municipality, 200003
Wen-Ping Xu, MD. PhD, (+86-21)15026590980, xwp198527@sina.com
Weifen Xie, MD. PhD, (+86-21)13701682806, weifenxie@medmail.com.cn
About this study
Official title: A Clinical Trial Assessing the Safety and Efficacy of Intravenous HNF4α SrRNA for the Treatment of Patients With Metastatic Colorectal Cancer
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.
Read the detailed description
This study will administer HNF4α srRNA via intravenous injection to treat locally unresectable or metastatic colorectal cancer. The second treatment will be conducted 14 ± 3 days after the initial treatment, with subsequent treatment cycles every 28 ± 7 days (the dosing interval will be adjusted based on the tolerability, safety, and therapeutic effect of the subjects). The dose-escalation trial will employ the i3+3 design method, with three dose groups, tentatively setting the injection dose of HNF4α srRNA at 25 μg, 50 μg, and 100 μg per administration, and each group is expected to include up to 3 subjects.
According to Amendment 1, after enrollment, the investigator will determine the HNF4α srRNA dose, whether to combine it with immunotherapy, and the dose and schedule of the combination, based on the patient's treatment history and the safety/efficacy data of HNF4α srRNA (CD-801/CD-GA-102) administered via peripheral vein for hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), or colorectal cancer (CRC). Participants initially on HNF4α srRNA monotherapy who are considered for combination with immunotherapy must complete at least two treatment cycles and the post - treatment safety assessment. Then, the investigator can decide whether to add immunotherapy after a comprehensive review of their treatment history.
- Conditions
- Metastatic Colorectal Cancer (mCRC)
- Being tested
- HNF4α srRNA
- Keywords
- colorectal cancer, Hepatocyte nuclear factor 4α
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HNF4α srRNADrug
HNF4α srRNA will be administered intravenously for the treatment of metastatic colorectal cancer. The dosing regimen is planned for a second dose 14 ± 3 days post-initial treatment, followed by subsequent treatments every 28 ± 7 days, with adjustments made based on patient tolerance and therapeutic response.
According to Amendment 1, after enrollment, the investigator will determine the HNF4α srRNA dose, whether to combine it with immunotherapy, and the dose and schedule of the combination, based on the patient's treatment history and the safety/efficacy data of HNF4α srRNA administered via peripheral vein for hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or colorectal cancer. Participants initially on HNF4α srRNA monotherapy who are considered for combination with immunotherapy must complete at least two treatment cycles and the post - treatment safety assessment.
| Study group | Role | What they receive |
|---|---|---|
| HNF4α srRNA treatment | Experimental | The subjects with metastatic colorectal cancer will be treated by HNF4α srRNA intravenously via a peripheral vein.
According to Amendment 1, the HNF4α srRNA preparation CD-801 used in the original protocol will expire on December 31, 2024. For participants receiving treatment after this date, the preparation will be switched to CD-GA-102, with the treatment dose converted on a 1:1 basis. Receives: Drug: HNF4α srRNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the tolerability and safety for intravenous HNF4α srRNA in subjects with metastatic colorectal cancer
Safety and tolerability are assessed based on the incidence of Dose-Limiting Toxicities (DLTs) within 14 days post-initial drug administration, along with the frequency and severity of adverse events (AEs), serious adverse events (SAEs), and events leading to treatment discontinuation throughout the treatment period, all evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
According to Amendment 1, the primary endpoint has been amended from assessing the incidence and severity of DLTs, adverse events (AEs), serious adverse events (SAEs), and AEs leading to treatment discontinuation (evaluated per NCI-CTCAE 5.0) with HNF4α srRNA therapy to assessing these outcomes for both HNF4α srRNA monotherapy and combination therapy.
Measured: Through study completion, an average of 2 years
Secondary outcomes (10)
To assess the objective response rate (ORR) by RECIST v1.1
To assess the proportion of subjects who have best overall response of complete response or partial response at the time of data cutoff based on RECIST v1.1.
According to Amendment 1, the secondary endpoint has also been updated from evaluating the ORR per RECIST v1.1 with HNF4α srRNA therapy to evaluating the ORR for both monotherapy and combination therapy with HNF4α srRNA per RECIST v1.1.
Measured: From the first study dose date until the date of documented complete response or partial response, assessed up to 24 months.
Duration of response based on RECIST v1.1
To assess the time from the first documentation of complete response or partial response to the date of first documentation of disease progression or death (whichever occurs first) based on RECIST v1.1
Measured: up to 24 months
Progression-free survival based on RECIST v1.1
To assess the time from the first study dose date to the date of first documentation of disease progression or death(whichever occurs first) based on RECIST v1.1
Measured: up to 24 months
Time to response based on RECIST v1.1
To assess the time from the date of first study dose to the date of first documentation of complete response or partial response based on RECIST v1.1
Measured: up to 24 months
Clinical benefit rate based on RECIST v1.1
To assess the proportion of subjects who have best overall response of complete response or partial response or durable stable disease (duration of stable disease ≥ 23 weeks) based on RECIST v1.1
Measured: up to 24 months
Overall Survival
To assess the time from the first study dose date until date of death from any cause . Subjects who are lost to follow-up and the subjects who are alive at the date of data cutoff will be censored at the date the subject was last known alive or the cut-off date, whichever comes earlier.
Measured: Throughout the entire course of treatment until the end of the follow-up period, an average of 2 years
Patient Reported Outcome-1
the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The maximum and minimum values of the EORTC QLQ-C30 questionnaire depend on the specific items and domains. For items with 7 levels, the maximum value is 7 points, and the minimum value is 1 point; for items with 4 levels, the maximum value is 4 points, and the minimum value is 1 point. In the standardized scores, the theoretical maximum score is 100 points, and the minimum score is 0 points. However, under normal circumstances, a higher score does not always represent a better outcome, as the interpretation of the scores needs to be based on the specific items and domains of the scale.
Measured: Through study completion, an average of 2 years
Patient Reported Outcome-2
Functional Assessment of Cancer Therapy Cololrectal Cancer (FACT-C). Each item has 5 levels, ranging from none to extreme. For assessments of functioning and overall health status, a higher score indeed indicates better patient conditions. However, for some symptom scales, such as pain or fatigue, a higher score actually signifies more severe issues.
Measured: Through study completion, an average of 2 years
Patient Reported Outcome-3
The Generic Euroquol Five Dimension Five Level (EQ-5D-5L) Questionnaire. The EQ-5D-5L includes five dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression, each with 5 levels ranging from \'No problems\' to \'Unable to perform/Extremely severe\'. In addition, there is a Visual Analogue Scale (EQ VAS), which ranges from 0 (the worst health state you can imagine) to 100 (the best health state you can imagine). The EQ VAS score reflects an individual assessment of their overall health status. The scores of the EQ-5D-5L are not necessarily better when they are higher, as they reflect the individual health status relative to societal preferences.
Measured: Through study completion, an average of 2 years
The impact of HNF4α srRNA treatment on tumor biomarkers in serum
The changes in tumor markers after treatment, including CA19-9, and carcinoembryonic antigen (CEA)
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 posted1 Oct 2024
- Study start12 Nov 2024
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (mCRC)Studies 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
- Model description
- The subjects with metastatic colorectal cancer will be treated by HNF4α srRNA intravenously via a peripheral vein.
- Masking
- None (open label)
- Enrolment
- 9 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
- Wei-Fen Xie, MD. PhD, Principal investigator, Naval Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621173
- Sponsor's protocol ID
- CZXH-CRC-2024-IIT
- Status last verified
- Apr 2025
- First submitted
- 24 Sep 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Assessing the Safety and Efficacy of Intravenous HNF4α SrRNA for the Treatment of Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06621173
- Acronym / sponsor ID
- CZXH-CRC-2024-IIT
- Conditions
- Metastatic Colorectal Cancer (mCRC)
- Keywords
- colorectal cancer, Hepatocyte nuclear factor 4α
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 1 Oct 2024 (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 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.
Detailed description
This study will administer HNF4α srRNA via intravenous injection to treat locally unresectable or metastatic colorectal cancer. The second treatment will be conducted 14 ± 3 days after the initial treatment, with subsequent treatment cycles every 28 ± 7 days (the dosing interval will be adjusted based on the tolerability, safety, and therapeutic effect of the subjects). The dose-escalation trial will employ the i3+3 design method, with three dose groups, tentatively setting the injection dose of HNF4α srRNA at 25 μg, 50 μg, and 100 μg per administration, and each group is expected to include up to 3 subjects.
According to Amendment 1, after enrollment, the investigator will determine the HNF4α srRNA dose, whether to combine it with immunotherapy, and the dose and schedule of the combination, based on the patient's treatment history and the safety/efficacy data of HNF4α srRNA (CD-801/CD-GA-102) administered via peripheral vein for hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), or colorectal cancer (CRC). Participants initially on HNF4α srRNA monotherapy who are considered for combination with immunotherapy must complete at least two treatment cycles and the post - treatment safety assessment. Then, the investigator can decide whether to add immunotherapy after a comprehensive review of their treatment history.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The subjects with metastatic colorectal cancer will be treated by HNF4α srRNA intravenously via a peripheral vein.
| Arm | Type | Receives |
|---|---|---|
| HNF4α srRNA treatment | Experimental | Drug: HNF4α srRNAThe subjects with metastatic colorectal cancer will be treated by HNF4α srRNA intravenously via a peripheral vein. According to Amendment 1, the HNF4α srRNA preparation CD-801 used in the original protocol will expire on December 31, 2024. For participants receiving treatment after this date, the preparation will be switched to CD-GA-102, with the treatment dose converted on a 1:1 basis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 subjects 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 chemotherapy based on fluorouracil, oxaliplatin, or irinotecan, and targeted therapies with anti-VEGF/EGFR monoclonal antibodies.
- 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 assessed with disease progression.
- According to the RECIST (version 1.1) criteria, there are measurable target lesions suitable for repeated measurements for assessment.
Key exclusion criteria (21 listed)
- Patients with any of the following criteria were excluded from participation in this study
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 |
|---|---|---|
| HNF4α srRNAHNF4α srRNA will be administered intravenously for the treatment of metastatic colorectal cancer. The dosing regimen is planned for a second dose 14 ± 3 days post-initial treatment, followed by subsequent treatments every 28 ± 7 days, with adjustments made based on patient tolerance and therapeutic response. According to Amendment 1, after enrollment, the investigator will determine the HNF4α srRNA dose, whether to combine it with immunotherapy, and the dose and schedule of the combination, based on the patient's treatment history and the safety/efficacy data of HNF4α srRNA administered via peripheral vein for hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or colorectal cancer. Participants initially on HNF4α srRNA monotherapy who are considered for combination with immunotherapy must complete at least two treatment cycles and the post - treatment safety assessment. | Drug | HNF4α srRNA treatment |
Primary outcome
To evaluate the tolerability and safety for intravenous HNF4α srRNA in subjects with metastatic colorectal cancer
Time frame: Through study completion, an average of 2 years
Safety and tolerability are assessed based on the incidence of Dose-Limiting Toxicities (DLTs) within 14 days post-initial drug administration, along with the frequency and severity of adverse events (AEs), serious adverse events (SAEs), and events leading to treatment discontinuation throughout the treatment period, all evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. According to Amendment 1, the primary endpoint has been amended from assessing the incidence and severity of DLTs, adverse events (AEs), serious adverse events (SAEs), and AEs leading to treatment discontinuation (evaluated per NCI-CTCAE 5.0) with HNF4α srRNA therapy to assessing these outcomes for both HNF4α srRNA monotherapy and combination therapy.
10 secondary outcomes
To assess the objective response rate (ORR) by RECIST v1.1
Time frame: From the first study dose date until the date of documented complete response or partial response, assessed up to 24 months.
Duration of response based on RECIST v1.1
Time frame: up to 24 months
Progression-free survival based on RECIST v1.1
Time frame: up to 24 months
Time to response based on RECIST v1.1
Time frame: up to 24 months
Clinical benefit rate based on RECIST v1.1
Time frame: up to 24 months
Overall Survival
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
Time frame: Through study completion, an average of 2 years
Patient Reported Outcome-2
Time frame: Through study completion, an average of 2 years
Patient Reported Outcome-3
Time frame: Through study completion, an average of 2 years
The impact of HNF4α srRNA treatment on tumor biomarkers in serum
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 24 Apr 2025.
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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.
Wei-Fen 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 HNF4α srRNA in people with Metastatic Colorectal Cancer (mCRC), 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 21 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 24 Apr 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 Beifang Ning, MD. PhD (13764001892, ningbeifang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the tolerability and safety for intravenous HNF4α srRNA in subjects with metastatic colorectal cancer (time frame: Through study completion, an average of 2 years). 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 24 Apr 2025.