Colorectal CancerPhase 1NCT07409805
YMN-136 Vaccine for Patients With Liver Metastasis of Colorectal Cancer Progressing After Third-Line Treatment
A Phase 1 study testing YMN-136 Vaccine in people with Colorectal Cancer, run by West China Hospital at 1 site in China.
Trial summary
This study aims to determine the safety and maximum tolerated dose (MTD) of YMN-136 vaccine through a dose escalation trial, and to investigate whether YMN-136 vaccine can assist in the treatment of patients with metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- YMN-136 Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2026to 1 Jun 2029
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form, be able to understand and agree to follow the prescribed research procedures and visits;
- Aged 18-75 years, both male and female are eligible;
- Histologically confirmed unresectable advanced colorectal adenocarcinoma;
- Patients with colorectal cancer liver metastasis who have failed third-line treatment, defined as those who have experienced disease progression (based on RECIST 1.1 criteria) or terminated treatment due to intolerance to toxicity after completing at least three different treatment regimens in the standard sequence during systemic treatment for colorectal cancer. The specific treatment pathway usually includes:
- First-line treatment: Chemotherapy combined with targeted drugs (such as FOLFOX/FOLFIRI combined with anti-EGFR cetuximab or anti-VEGF bevacizumab).
- Second-line treatment: Switch to a different chemotherapy regimen (e.g., FOLFIRI for second-line treatment if FOLFOX was used for first-line treatment) and replace the targeted drug (e.g., alternating between anti-EGFR and anti-VEGF drugs).
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- Third-line treatment: Standard third-line drugs include Regorafenib, TAS-102, or Furadixone, or novel drugs participating in clinical trials.
- Eastern Cooperative Oncology Group (ECOG) physical status score: 0 or 1;
- Expected survival ≥12 weeks;
- During the screening period, the organ function levels must meet the following requirements:
- Absolute neutrophil count (ANC) ≥1.5×10^9/L;
- Platelet count (PLT) ≥100×10^9/L;
- Hemoglobin (Hb) ≥90g/L;
- Total bilirubin (TBIL) ≤1.5×ULN;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, and ≤5×ULN for patients with liver metastasis;
- Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance rate (Cockcroft-Gault formula) ≥45 mL/min;
- International normalized ratio (INR), prothrombin time (PT) ≤1.5×ULN;
- QTc interval calculated according to Fridericia criteria, ≤450ms for males and ≤470ms for females; • Urine routine test/24-hour urine protein quantitation: urine protein qualitative test ≤1+ (if urine protein qualitative test ≥2+, then 24-hour urine protein <1g is acceptable for enrollment);
- Cardiac function: left ventricular ejection fraction ≥50%
- Qualified patients (males or females) with reproductive capacity must agree to use a medically approved physical contraceptive method (such as intrauterine device, condom, tubal or vasectomy ligation, etc.) during the trial period and within 6 months after the last dose; female patients of childbearing age must have negative serum or urine HCG test results during the screening period.
Who cannot join
- Patients with extensive peritoneal metastasis or intestinal obstruction; patients with uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- Patients known to be allergic to the components of the investigational drug (such as lipid nanoparticles, RNA vectors) or similar drugs;
- Patients who have previously received vaccine therapy;
- Patients who have received chemotherapy, targeted therapy, or immunotherapy within 4 weeks before the first dose;
- During the dose escalation and dose expansion phases: Patients who have received anti-tumor treatment, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, biotherapy, or treatment with drugs from other clinical trials, within 4 weeks or 5 drug half-lives (whichever is shorter, but at least 14 days) before the first dose; Patients who have taken traditional Chinese medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications within 14 days before the first dose;
- Patients who are expected to use immunosuppressive drugs during the study period within 4 weeks before the first dose, except for corticosteroid nasal sprays, inhalants, or systemic prednisone ≤10 mg/day and equivalent treatments;
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- Patients with a history of organ transplantation, bone marrow transplantation, or hematopoietic stem cell transplantation;
- Patients who have received attenuated live vaccines within 28 days before the first dose;
- During the dose escalation and dose expansion phases: Patients with symptomatic, untreated, or requiring continuous treatment (including corticosteroids and antiepileptic drugs) for central nervous system (CNS) metastasis (previously treated patients who have had stable clinical symptoms for at least 4 weeks before enrollment, have excluded evidence of new or expanding metastasis, and have discontinued steroid treatment may be enrolled; patients with asymptomatic brain metastasis and no need for treatment may be enrolled);
- During the dose escalation and dose expansion phases: Patients who have not recovered to baseline or grade 0-1 (excluding alopecia and pigmentation) as defined by NCI CTCAE v5.0 after previous anti-tumor treatment. Patients with reasonably expected irreversible toxicity that will not be exacerbated by the study drug may be enrolled after confirmation with the investigator;
- Patients with a history of autoimmune diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease, etc. Type 1 diabetes, hypothyroidism that can be controlled only by replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo and psoriasis) can be included in the trial;
- history of immediate hypersensitivity reactions, eczema or asthma that cannot be controlled by topical corticosteroids;
- history of other malignant tumors, except for curable tumors that have been cured, such as basal or squamous cell skin cancer, superficial bladder cancer or cervical carcinoma in situ, and breast carcinoma in situ.
- Concurrent uncontrollable concomitant diseases, including but not limited to: unexplained fever > 38.5°C (subjects with tumor-related fever to be determined by the investigator for inclusion in the study), symptomatic congestive heart failure with New York Heart Association (NYHA) functional class ≥2, left ventricular ejection fraction (LVEF) <50%, poorly controlled hypertension (systolic blood pressure >160mmHg and/or diastolic blood pressure >100mmHg after treatment, and clinically significant as assessed by the investigator), unstable angina or acute myocardial infarction within 3 months prior to the first dose, poorly controlled arrhythmia; patients with chronic obstructive pulmonary disease, asthma, interstitial lung disease, and decreased lung function;
- patients with active infection who currently require systemic anti-infective treatment; patients with active tuberculosis;
- known human immunodeficiency virus (HIV)-positive individuals, individuals with active syphilis spirochete infection; individuals who are HBsAg and/or HBcAb positive and HBV-DNA >500 IU/L; individuals who are HCV-RNA positive;
- patients with an expected survival of <3 months (based on clinical assessment or Child-Pugh C liver function).
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
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Dan Cao, +8618980605963, caodan@scu.edu.cn
Manni Wang, wangnanni@scu.edu.cn
About this study
Official title: Evaluation of Safety and Efficacy of YMN-136 Vaccine in Patients With Liver Metastasis of Colorectal Cancer Progressing After Third-Line Treatment: A Prospective Phase I Clinical Study
This study aims to determine the safety and maximum tolerated dose (MTD) of YMN-136 vaccine through a dose escalation trial, and to investigate whether YMN-136 vaccine can assist in the treatment of patients with metastatic colorectal cancer.
- Conditions
- Colorectal Cancer
- Being tested
- YMN-136 Vaccine
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YMN-136 VaccineBiological
The YMN-136 vaccine will be administered according to the dose level assigned to each patient. Approximately every 3 weeks, the vaccine will be administered via intramuscular injection into the single upper arm, with 4 doses for prime immunization.
| Study group | Role | What they receive |
|---|---|---|
| YMN-136 vaccine treatment | Experimental | Not described Receives: Biological: YMN-136 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Related Adverse Events
Number of participants experiencing treatment-related adverse events, serious adverse events, dose-limiting toxicities,and adverse events leading to treatment discontinuation, graded according to NCI CTCAE v5.0
Measured: Approximately 24 months
Determine the maximum tolerated dose (MTD) and recommended phase II clinical trial dose (RP2D) for the YMN-136 vaccine.
RP2D will be determined on the basis of evaluation on safety and efficacy data in dose escalation stages.
Measured: Approximately 24 months
Secondary outcomes (4)
Disease Control Rate (DCR)
Proportion of participants achieving complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1 criteria
Measured: Approximately 24 months
Progression-Free Survival (PFS)
Time from study enrollment to disease progression or death from any cause, whichever occurs first, according to RECIST v1.1 criteria
Measured: Approximately 24 months
Overall Survival (OS)
Time from study enrollment to death from any cause
Measured: Approximately 24 months
Duration of Response (DoR)
Time from first documented objective response (CR or PR) to disease progression or death from any cause, whichever occurs first, according to RECIST v1.1 criteria
Measured: Approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start6 May 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Cao, West China Hospital
- Investigators
- Dan Cao, Principal investigator, Division of Abdominal Tumor, Department of Medical Oncology, Cancer Center and State Key Laboratory of Biological Therapy, West China Hospital, Sichuan University, Chengdu, Sichuan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409805
- Sponsor's protocol ID
- 2025(2266)
- Status last verified
- May 2026
- First submitted
- 14 Jan 2026
- Last updated
- 29 Jul 2026
- 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of YMN-136 Vaccine in Patients With Liver Metastasis of Colorectal Cancer Progressing After Third-Line Treatment: A Prospective Phase I Clinical Study
- ClinicalTrials.gov ID
- NCT07409805
- Acronym / sponsor ID
- 2025(2266)
- Conditions
- Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 6 May 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 13 Feb 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 aims to determine the safety and maximum tolerated dose (MTD) of YMN-136 vaccine through a dose escalation trial, and to investigate whether YMN-136 vaccine can assist in the treatment of patients with metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YMN-136 vaccine treatment | Experimental | Biological: YMN-136 Vaccine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Voluntarily sign the informed consent form, be able to understand and agree to follow the prescribed research procedures and visits;
- Aged 18-75 years, both male and female are eligible;
- Histologically confirmed unresectable advanced colorectal adenocarcinoma;
- Patients with colorectal cancer liver metastasis who have failed third-line treatment, defined as those who have experienced disease progression (based on RECIST 1.1 criteria) or terminated treatment due to intolerance to toxicity after completing at least three different treatment regimens in the standard sequence during systemic treatment for colorectal cancer. The specific treatment pathway usually includes:
- Eastern Cooperative Oncology Group (ECOG) physical status score: 0 or 1;
Key exclusion criteria (17 listed)
- Patients with extensive peritoneal metastasis or intestinal obstruction; patients with uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- Patients known to be allergic to the components of the investigational drug (such as lipid nanoparticles, RNA vectors) or similar drugs;
- Patients who have previously received vaccine therapy;
- Patients who have received chemotherapy, targeted therapy, or immunotherapy within 4 weeks before the first dose;
- During the dose escalation and dose expansion phases: Patients who have received anti-tumor treatment, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, biotherapy, or treatment with drugs from other clinical trials, within 4 weeks or 5 drug half-lives (whichever is shorter, but at least 14 days) before the first dose; Patients who have taken traditional Chinese medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications within 14 days before the first dose;
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-136 VaccineThe YMN-136 vaccine will be administered according to the dose level assigned to each patient. Approximately every 3 weeks, the vaccine will be administered via intramuscular injection into the single upper arm, with 4 doses for prime immunization. | Biological | YMN-136 vaccine treatment |
Primary outcome
Incidence of Treatment-Related Adverse Events
Time frame: Approximately 24 months
Number of participants experiencing treatment-related adverse events, serious adverse events, dose-limiting toxicities,and adverse events leading to treatment discontinuation, graded according to NCI CTCAE v5.0
Determine the maximum tolerated dose (MTD) and recommended phase II clinical trial dose (RP2D) for the YMN-136 vaccine.
Time frame: Approximately 24 months
RP2D will be determined on the basis of evaluation on safety and efficacy data in dose escalation stages.
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: Approximately 24 months
Progression-Free Survival (PFS)
Time frame: Approximately 24 months
Overall Survival (OS)
Time frame: Approximately 24 months
Duration of Response (DoR)
Time frame: Approximately 24 months
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 29 Jul 2026.
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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.
Dan Cao principal investigator
Division of Abdominal Tumor, Department of Medical Oncology, Cancer Center and State Key Laboratory of Biological Therapy, West China Hospital, Sichuan University, Chengdu, Sichuan
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-136 Vaccine in people with Colorectal Cancer, 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 20 inclusion and 17 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 29 Jul 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 Dan Cao (+8618980605963, caodan@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Related Adverse Events (time frame: Approximately 24 months). The study lists 2 primary outcomes in all. 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 29 Jul 2026.