Colorectal Cancer With Liver MetastaticPhase 1NCT07610707
YMN-A02 for Advanced pMMR Colorectal Cancer With Liver Metastases
A Phase 1 study testing YMN-A02 100μg, YMN-A02 250μg and YMN-A02 500μg in people with Colorectal Cancer With Liver Metastatic, run by West China Hospital at 1 site in China.
Trial summary
This study was a prospective, single-center, open-label, single-arm, multi-dose ascending phase Ⅰ clinical trial. The investigators constructed a TM10-LNP mRNA preparation encoding CTLA-4 antibody and TGF-β trap bifunction protein (YMN-A02 bifunction RNA preparation). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer With Liver Metastatic
- What is being tested?
- YMN-A02 100μg, YMN-A02 250μg and YMN-A02 500μg
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2026to 30 Jun 2028
- Phase
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed the informed consent form approved by the ethics committee.
- 18-70 years old; ECOG performance status 0-1.
- Histologically or cytologically confirmed colorectal cancer with liver metastases, molecularly classified as pMMR (presence of other distant metastases allowed).
- Patients who have failed or are intolerant to standard therapy, or who refuse standard therapy.
- For patients with RAS/BRAF wild-type and eligible for targeted therapy: enrollment allowed only after disease progression on a prior standard regimen containing anti-EGFR or anti-VEGF monoclonal antibody.
- For patients with BRAF V600E mutation: enrollment allowed only after failure of a prior BRAF inhibitor-containing chemotherapy regimen.
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- For patients who do not meet the above molecular characteristics: enrollment allowed only after failure of at least two prior lines of systemic chemotherapy (including a platinum-containing regimen).
- At least one measurable liver metastasis (CT scan long diameter ≥10 mm, slice thickness ≤5 mm).
- Life Expectancy≥3 months.
- Adequate Major Organ Function (all within 14 days before randomization):
- Hemoglobin ≥80 g/L (no transfusion within 14 days); absolute neutrophil count >1.5×10⁹/L; platelet count ≥80×10⁹/L.
- Total bilirubin ≤1.5×ULN; ALT/AST ≤2.5×ULN (or ≤5×ULN in the presence of liver metastases); creatinine clearance ≥60 mL/min (Cockcroft-Gault formula).
- Left ventricular ejection fraction (LVEF) ≥50%.
- Good compliance, and family agrees to cooperate with survival follow-up.
Who cannot join
- Participation in another interventional drug trial within 4 weeks before enrollment.
- Prior or concurrent other malignancy, except: carcinoma in situ of the cervix, cutaneous squamous cell carcinoma, superficial bladder tumor, or any other malignancy that has been curatively treated and recurrence-free for ≥5 years.
- Poorly controlled heart disease or clinical symptoms, including but not limited to: NYHA class ≥2 heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
- Pregnant or breastfeeding women.
- Active infection, including but not limited to: active tuberculosis, systemic bacterial or fungal infection (NCI-CTCAE v5.0 grade ≥2), HIV infection, active HBV (HBV DNA >ULN), or active HCV (HCV RNA >ULN).
- History of substance abuse that cannot be abstained from, or history of psychiatric disorders.
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- Active or history of autoimmune disease (including but not limited to uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism, etc.). Exceptions: vitiligo controlled with only topical agents; childhood asthma completely resolved without any intervention in adulthood. Patients with asthma requiring bronchodilators for medical intervention are excluded.
- Prior vaccination with any mRNA-based drug or mRNA formulation.
- Prior participation in any clinical trial involving lipid nanoparticle (LNP) formulations.
- Contraindications to intravenous infusion.
- History of drug abuse, or any medical, psychological, or social condition (e.g., alcoholism or drug addiction) that, in the investigator's judgment, may affect study compliance.
- Known allergy, hypersensitivity, or intolerance to any component (active substance or excipients) of the study drug; history of severe allergy to drugs, food, or vaccines, including but not limited to anaphylactic shock, angioedema of the larynx, anaphylactic dyspnea, allergic purpura, thrombocytopenic purpura, or Arthus reaction.
- Plan to conceive (either female subject or partner of male subject) from screening through 12 months after the last dose.
- Any concurrent condition that, in the investigator's judgment, may compromise patient safety or interfere with study completion.
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
West China Hospital
Chengdu, Sichuan, 610041
Peng Xingchen Professor, 86-18980606753, pxx2014@scu.edu.cn
About this study
Official title: A Phase I Clinical Trial of YMN-A02 in Patients With Advanced pMMR Colorectal Cancer and Liver Metastases: Safety, Tolerability, and Preliminary Efficacy
This study was a prospective, single-center, open-label, single-arm, multi-dose ascending phase Ⅰ clinical trial. The investigators constructed a TM10-LNP mRNA preparation encoding CTLA-4 antibody and TGF-β trap bifunction protein (YMN-A02 bifunction RNA preparation). The aim of this study is to provide a new strategy for overcoming the immune tolerance of liver tumors and improving the response rate of immunotherapy. The investigators planned to enroll patients with advanced pMMR liver metastasis from colorectal cancer who failed standard treatment. A modified "3+3" design was used, and 10 patients were expected to be enrolled. There were four dose groups of 100μg, 250μg, 500μg and 1000μg. The trial used a modified "3+3" dose climbing design, in which one subject was set as a sentinel patient in the initial 100μg dose group. If the subject did not experience DLT during the DLT observation period, the dose was judged safe and escalation to the next group occurred. If DLT occurred, 3 additional subjects in this group would be required for further evaluation. In the subsequent 250μg, 500μg, and 1000μg dose groups, three subjects were enrolled first in each group: if there was no DLT, the number of subjects was increased. If ≥2 of the 3 cases had DLT, the escalation was terminated. If DLT occurred in 1 out of 3 subjects, 3 additional observations would be made in the same dose group. If the incidence of DLT in the total 6 subjects did not exceed 1/6 after the supplement, the escalation could be escalated. Otherwise, the escalation was terminated and the dose was considered as intolerable.
- Conditions
- Colorectal Cancer With Liver Metastatic
- Being tested
- YMN-A02 100μg, YMN-A02 250μg, YMN-A02 500μg, YMN-A02 1000μg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YMN-A02 100μgBiological
Also called YMN-A02
Enrolled subjects will receive a 100 μg intravenous infusion according to their assigned dose group. The dosing regimen includes 5 doses of primary immunization followed by subsequent individualized treatment. The first 4 doses of primary immunization are administered once weekly (Q1W), and the 5th dose is administered one month after the 4th dose. The DLT observation period is from the first infusion to 14 days after the third infusion.
YMN-A02 250μgBiological
Enrolled subjects will receive a 250 μg intravenous infusion according to their assigned dose group. The dosing regimen includes 5 doses of primary immunization followed by subsequent individualized treatment. The first 4 doses of primary immunization are administered once weekly (Q1W), and the 5th dose is administered one month after the 4th dose. The DLT observation period is from the first infusion to 14 days after the third infusion.
YMN-A02 500μgBiological
Enrolled subjects will receive a 500 μg intravenous infusion according to their assigned dose group. The dosing regimen includes 5 doses of primary immunization followed by subsequent individualized treatment. The first 4 doses of primary immunization are administered once weekly (Q1W), and the 5th dose is administered one month after the 4th dose. The DLT observation period is from the first infusion to 14 days after the third infusion.
YMN-A02 1000μgBiological
Enrolled subjects will receive a 1000 μg intravenous infusion according to their assigned dose group. The dosing regimen includes 5 doses of primary immunization followed by subsequent individualized treatment. The first 4 doses of primary immunization are administered once weekly (Q1W), and the 5th dose is administered one month after the 4th dose. The DLT observation period is from the first infusion to 14 days after the third infusion.
| Study group | Role | What they receive |
|---|---|---|
| YMN-A02 100 μg Group | Experimental | Enrolled subjects will receive a 100 μg intravenous infusion. Receives: Biological: YMN-A02 100μg |
| YMN-A02 250 μg Group | Experimental | Enrolled subjects will receive a 250 μg intravenous infusion. Receives: Biological: YMN-A02 250μg |
| YMN-A02 500 μg Group | Experimental | Enrolled subjects will receive a 500 μg intravenous infusion. Receives: Biological: YMN-A02 500μg |
| YMN-A02 1000 μg Group | Experimental | Enrolled subjects will receive a 1000 μg intravenous infusion. Receives: Biological: YMN-A02 1000μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Dose-Limiting Toxicity (DLT)
Observe and record the occurrence of DLTs. DLT is defined as treatment-related adverse events or clinically significant laboratory abnormalities occurring during the DLT observation period, graded according to NCI CTCAE v5.0.
Measured: From first dose to 14 days after the third dose, approximately Day 0 to Day 42
Secondary outcomes (2)
Progression-Free Survival (PFS)
Assess disease progression per RECIST v1.1, calculating the time from start of treatment to first documented disease progression or death from any cause.
Measured: Within 2 years after the first dose
Objective Response Rate (ORR)
Tumor response assessed per RECIST v1.1 for solid tumors. ORR is the proportion of patients whose tumor volume reduction reaches a predefined value and is maintained for a minimum required duration, calculated as the sum of complete response (CR) and partial response (PR) rates.
Measured: Within 6 months after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 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 With Liver MetastaticStudies of the same condition, open and under way.
- More trials run by West China 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610707
- Sponsor's protocol ID
- 2026(890)
- Status last verified
- May 2026
- First submitted
- 26 Apr 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial of YMN-A02 in Patients With Advanced pMMR Colorectal Cancer and Liver Metastases: Safety, Tolerability, and Preliminary Efficacy
- ClinicalTrials.gov ID
- NCT07610707
- Acronym / sponsor ID
- 2026(890)
- Conditions
- Colorectal Cancer With Liver Metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 28 May 2026 (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 was a prospective, single-center, open-label, single-arm, multi-dose ascending phase Ⅰ clinical trial. The investigators constructed a TM10-LNP mRNA preparation encoding CTLA-4 antibody and TGF-β trap bifunction protein (YMN-A02 bifunction RNA preparation). The aim of this study is to provide a new strategy for overcoming the immune tolerance of liver tumors and improving the response rate of immunotherapy. The investigators planned to enroll patients with advanced pMMR liver metastasis from colorectal cancer who failed standard treatment. A modified "3+3" design was used, and 10 patients were expected to be enrolled. There were four dose groups of 100μg, 250μg, 500μg and 1000μg. The trial used a modified "3+3" dose climbing design, in which one subject was set as a sentinel patient in the initial 100μg dose group. If the subject did not experience DLT during the DLT observation period, the dose was judged safe and escalation to the next group occurred. If DLT occurred, 3 additional subjects in this group would be required for further evaluation. In the subsequent 250μg, 500μg, and 1000μg dose groups, three subjects were enrolled first in each group: if there was no DLT, the number of subjects was increased. If ≥2 of the 3 cases had DLT, the escalation was terminated. If DLT occurred in 1 out of 3 subjects, 3 additional observations would be made in the same dose group. If the incidence of DLT in the total 6 subjects did not exceed 1/6 after the supplement, the escalation could be escalated. Otherwise, the escalation was terminated and the dose was considered as intolerable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| YMN-A02 100 μg Group | Experimental | Biological: YMN-A02 100μgEnrolled subjects will receive a 100 μg intravenous infusion. |
| YMN-A02 250 μg Group | Experimental | Biological: YMN-A02 250μgEnrolled subjects will receive a 250 μg intravenous infusion. |
| YMN-A02 500 μg Group | Experimental | Biological: YMN-A02 500μgEnrolled subjects will receive a 500 μg intravenous infusion. |
| YMN-A02 1000 μg Group | Experimental | Biological: YMN-A02 1000μgEnrolled subjects will receive a 1000 μg intravenous infusion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed the informed consent form approved by the ethics committee.
- 18-70 years old; ECOG performance status 0-1.
- Histologically or cytologically confirmed colorectal cancer with liver metastases, molecularly classified as pMMR (presence of other distant metastases allowed).
- Patients who have failed or are intolerant to standard therapy, or who refuse standard therapy.
- At least one measurable liver metastasis (CT scan long diameter ≥10 mm, slice thickness ≤5 mm).
Key exclusion criteria (14 listed)
- Participation in another interventional drug trial within 4 weeks before enrollment.
- Prior or concurrent other malignancy, except: carcinoma in situ of the cervix, cutaneous squamous cell carcinoma, superficial bladder tumor, or any other malignancy that has been curatively treated and recurrence-free for ≥5 years.
- Poorly controlled heart disease or clinical symptoms, including but not limited to: NYHA class ≥2 heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
- Pregnant or breastfeeding women.
- Active infection, including but not limited to: active tuberculosis, systemic bacterial or fungal infection (NCI-CTCAE v5.0 grade ≥2), HIV infection, active HBV (HBV DNA >ULN), or active HCV (HCV RNA >ULN).
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 |
|---|---|---|
| YMN-A02 100μgAlso: YMN-A02Enrolled subjects will receive a 100 μg intravenous infusion according to their assigned dose group. The dosing regimen includes 5 doses of primary immunization followed by subsequent individualized treatment. The first 4 doses of primary immunization are administered once weekly (Q1W), and the 5th dose is administered one month after the 4th dose. The DLT observation period is from the first infusion to 14 days after the third infusion. | Biological | YMN-A02 100 μg Group |
| YMN-A02 250μgEnrolled subjects will receive a 250 μg intravenous infusion according to their assigned dose group. The dosing regimen includes 5 doses of primary immunization followed by subsequent individualized treatment. The first 4 doses of primary immunization are administered once weekly (Q1W), and the 5th dose is administered one month after the 4th dose. The DLT observation period is from the first infusion to 14 days after the third infusion. | Biological | YMN-A02 250 μg Group |
| YMN-A02 500μgEnrolled subjects will receive a 500 μg intravenous infusion according to their assigned dose group. The dosing regimen includes 5 doses of primary immunization followed by subsequent individualized treatment. The first 4 doses of primary immunization are administered once weekly (Q1W), and the 5th dose is administered one month after the 4th dose. The DLT observation period is from the first infusion to 14 days after the third infusion. | Biological | YMN-A02 500 μg Group |
| YMN-A02 1000μgEnrolled subjects will receive a 1000 μg intravenous infusion according to their assigned dose group. The dosing regimen includes 5 doses of primary immunization followed by subsequent individualized treatment. The first 4 doses of primary immunization are administered once weekly (Q1W), and the 5th dose is administered one month after the 4th dose. The DLT observation period is from the first infusion to 14 days after the third infusion. | Biological | YMN-A02 1000 μg Group |
Primary outcome
Occurrence of Dose-Limiting Toxicity (DLT)
Time frame: From first dose to 14 days after the third dose, approximately Day 0 to Day 42
Observe and record the occurrence of DLTs. DLT is defined as treatment-related adverse events or clinically significant laboratory abnormalities occurring during the DLT observation period, graded according to NCI CTCAE v5.0.
2 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Within 2 years after the first dose
Objective Response Rate (ORR)
Time frame: Within 6 months after the first dose
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 28 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YMN-A02 100μg, YMN-A02 250μg and YMN-A02 500μg in people with Colorectal Cancer With Liver Metastatic, run by West China 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 14 inclusion and 14 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: opening soon, as of the sponsor's last update on 28 May 2026. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Peng Xingchen Peng (86-17723609529, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Dose-Limiting Toxicity (DLT) (time frame: From first dose to 14 days after the third dose, approximately Day 0 to Day 42). 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 28 May 2026.