Solid Tumor MalignanciesEarly Phase 1NCT07182435
Exploratory Clinical Study of Personalized mRNA Tumor Vaccine RH125 in Patients With Advanced Solid Tumors
A Early Phase 1 study testing personalized neoantigen mRNA tumor vaccine in people with Solid Tumor Malignancies, run by Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center at 1 site in China.
Trial summary
This is a Phase 1 clinical study investigating RH125 as monotherapy or in combination therapy in patients with locally advanced or metastatic solid tumors who failed standard treatment, or were intolerant to standard treatment, or declined standard treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumor Malignancies
- What is being tested?
- personalized neoantigen mRNA tumor vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2025to 31 Dec 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged from 18 to 70 years old.
- Patients with histologically and radiologically confirmed locally advanced or metastatic solid tumors that are not suitable for curative surgical treatment, Eligible patients must have experienced disease progression following standard antitumor therapy or be unable or unwilling to receive standard treatments. Patients in the combination therapy group are suitable for PD-1 blockers therapy judged by the investigator .
- Patients must hava at least one measureble disease per RECIST 1.1.
- Patients must have a fresh tumor lession sample for sequencing and test of expression of PD-1(22c3,only for patients in the combination therapy group .)
- ECOG performance status of 0 or 1
- Life expectancy of at least 6 months.
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- Adequate organ and hematologic function, with no severe dysfunction of the heart, lungs, liver, kidneys, or immune system, based on the following laboratory values:
- 1). Hematology: ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 100 g/L. Within one week before screening, the subject must not have received blood or platelet transfusions, G-CSF, or erythropoietin (EPO); 2). Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula); 3). Liver function: AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver cancer or liver metastases); TBIL ≤ 1.5 × ULN (patients with Gilbert's syndrome: TBIL < 3 × ULN); 4). Coagulation: INR ≤ 1.5 × ULN or APTT ≤ 1.5 × ULN (except for patients on anticoagulants).
- 8.. Male subjects with reproductive potential and female subjects of childbearing potential agree to use effective contraception from the time of informed consent until 6 months after the last dose of investigational drug.
- Women of childbearing potential include premenopausal women and those within 2 years post-menopause.
- A negative serum pregnancy test is required within 7 days before the first dose of the investigational product.
Who cannot join
- Having active malignant tumors within 2 years before the first administration, except for any locally curable tumors that have received radical treatment (e.g., resected basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix or breast);
- Presecne of central nervous system metastases, carcinomatous meningitis, or primary central nervous system tumors.
- Results of predicted neoantigen epitopes is less than 5.
- Having received other anti-tumor treatments (such as chemotherapy, endocrine therapy, targeted therapy, immunotherapy, radiotherapy, or tumor embolization) within 4 weeks before the first vaccination; for oral fluoropyrimidines and small-molecule targeted drugs, the interval required is more than 2 weeks or 5 half-lives of the drug, whichever is longer.
- Clinically significant residual toxicity (≥ grade 2 per CTCAE v5.0) from previous treatment (including systemic therapy, radiotherapy, or surgery), except for alopecia, hyperpigmentation, or other AEs deemed by the investigator not to affect study safety and where recovery to grade ≤1 is not required.
- Prior one marrow transplantation, allogeneic hematopoietic stem cell transplantation or solid organ transplantation
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- Patients who need to take immunosuppressants regularly within 4 weeks before the first vaccination and during the clinical study, including but not limited to the following situations: those with severe asthma, autoimmune diseases or immunodeficiency, those receiving immunosuppressive drug therapy, or those with a known history of primary immunodeficiency; however, subjects with the following diseases are allowed to undergo further enrollment screening: type I diabetes with good control, hypothyroidism with good control requiring only hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia), or subjects whose condition is not expected to relapse without external triggers.
- Clinically diagnosed active bacterial or fungal infections; having active tuberculosis or a history of tuberculosis.
- Active hepatitis B virus (HBV) infection (defined as HBsAg positive and HBV-DNA > ULN), hepatitis C virus (HCV) infection (defined as HCV-Ab positive and HCV-RNA positive), human immunodeficiency virus (HIV) infection (HIV-Ab positive) or treponema pallidum(TP) infection.
- Severe cardiovascular diseases occurring within 2 years before the first administration, including but not limited to: stable angina pectoris with functional class III-IV; unstable angina pectoris or myocardial infarction; NYHA class III-IV congestive heart failure; severe arrhythmias requiring drug treatment.
- A history of substance abuse, or clinical, psychological, or social factors that may affect informed consent or the conduct of the study; a history of mental illness.
- A history of allergies to previous vaccinations, allergies to any component of the investigational product, a history of severe allergies to food or drugs, or other potential allergies to immunotherapy as deemed by the investigator.
- Pregnant or lactating women.
- Participation in other interventional clinical studies within 12 weeks before the first vaccination, except for participation in observational (non-interventional) clinical studies or being in the survival follow-up phase of interventional studies.
- Vaccination of any type within 28 days before administration.
- Subjects deemed unsuitable for enrollment by the investigator or who may be unable to complete the trial for other reasons.
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
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, 518100
Jianhua Chang, 86-18038168872, changjianhua@163.com
About this study
Official title: A Phase 1 Clinical Trial of Personalized mRNA Tumor Vaccine RH125 in Patients With Advanced or Metastatic Solid Tumors Evaluating the Safety, Tolerability, and Efficacy
This is a Phase 1 clinical study investigating RH125 as monotherapy or in combination therapy in patients with locally advanced or metastatic solid tumors who failed standard treatment, or were intolerant to standard treatment, or declined standard treatment. The aim of the study is to evaluate the tolerability, safety, immunogenicity, and preliminary efficacy of RH125 monotherapy or combination with PD-1 blocker.
Read the detailed description
This study will be divided into monotherapy dose escalation and combination therapy dose escalation phases. Each phase requires the enrollment of 12-18 subjects, with a total of 24-36 subjects to be enrolled in the entire study. Both the monotherapy dose escalation and combination therapy dose escalation will involve 3 dose levels, which are 100 μg, 150 μg, and 200 μg respectively. A "3+3" design will be adopted, and the Dose-Limiting Toxicity (DLT) observation period will be 21 days for both phases.
- Conditions
- Solid Tumor Malignancies
- Being tested
- personalized neoantigen mRNA tumor vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized neoantigen mRNA tumor vaccineBiological
RH125 is a personalized neoantigen mRNA tumor vaccine which is constructed based on the results of patients' neoantigen sequencing.
| Study group | Role | What they receive |
|---|---|---|
| escalation doses between 100μg, 150μg or 200μg of RH125 with or withoout PD-1 blockers | Experimental | Not described Receives: Biological: personalized neoantigen mRNA tumor vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Dose-Limiting Toxicities (DLT)
Measured: From Day 1 to Day 21 after the first dose
Number of Participants with Adverse Events per CTCAE 5.0
Measured: Up to approximately 24 months
Immunogenicity of a personalized cancer vaccine as measured by interferon-γ secreting T lymphocytes in peripheral blood mononuclear cells (PBMCs) using ELISpot
Measured: Up to approximately 24 months
Serious adverse events as graded by CTCAE v5.0
Measured: Up to approximately 24 months
adverse event of special interest as graded by CTCAE v5.0
Measured: Up to approximately 24 months
Secondary outcomes (6)
Objective Response Rate (ORR)
ORR is defined as the proportion of participants whose best overall response is complete response (CR) or partial response (PR) per RECIST 1.1.
Measured: Up to approximately 24 months
Disease Control Rate(DCR)
ORR is defined as the proportion of participants whose best overall response is complete response (CR) , partial response (PR) or stable disease (SD) per RECIST 1.1.
Measured: Up to approximately 24 months
Rime to response(TTR)
TTR is defined as time to the first tumor response (complete response (CR) or partial response (PR)) per RECIST 1.1.
Measured: Up to approximately 24 months
Duration of Response(DoR)
DoR is defined as time from first tumor response (partial or complete) until either radiological disease progression, clinical/symptomatic disease progression or death (whichever is sooner) per RECIST 1.1.
Measured: Up to approximately 24 months
Progression Free Survival(PFS)
PFS is defined as time between the date of first dose and the date of either radiological disease progression per RECIST 1.1, clinical/symptomatic disease progression or death (whichever is sooner).
Measured: Up to approximately 24 months
Overall Survival(OS)
OS is defined as time between the date of the first dose of study drug and the date of death due to any cause.
Measured: Up to 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 posted19 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor MalignanciesStudies of the same condition, open and under way.
- 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Binghe Xu, Principal investigator, Cancer Hospital Chinese Academy of Medical Science, Shenzhen CenterJianhua Chang, Principal investigator, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182435
- Sponsor's protocol ID
- RH125-0-01
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial of Personalized mRNA Tumor Vaccine RH125 in Patients With Advanced or Metastatic Solid Tumors Evaluating the Safety, Tolerability, and Efficacy
- ClinicalTrials.gov ID
- NCT07182435
- Acronym / sponsor ID
- RH125-0-01
- Conditions
- Solid Tumor Malignancies
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cancer Hospital Chinese Academy of Medical Science, Shenzhen CenterUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Sep 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 is a Phase 1 clinical study investigating RH125 as monotherapy or in combination therapy in patients with locally advanced or metastatic solid tumors who failed standard treatment, or were intolerant to standard treatment, or declined standard treatment. The aim of the study is to evaluate the tolerability, safety, immunogenicity, and preliminary efficacy of RH125 monotherapy or combination with PD-1 blocker.
Detailed description
This study will be divided into monotherapy dose escalation and combination therapy dose escalation phases. Each phase requires the enrollment of 12-18 subjects, with a total of 24-36 subjects to be enrolled in the entire study. Both the monotherapy dose escalation and combination therapy dose escalation will involve 3 dose levels, which are 100 μg, 150 μg, and 200 μg respectively. A "3+3" design will be adopted, and the Dose-Limiting Toxicity (DLT) observation period will be 21 days for both phases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| escalation doses between 100μg, 150μg or 200μg of RH125 with or withoout PD-1 blockers | Experimental | Biological: personalized neoantigen mRNA tumor vaccine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female, aged from 18 to 70 years old.
- Patients with histologically and radiologically confirmed locally advanced or metastatic solid tumors that are not suitable for curative surgical treatment, Eligible patients must have experienced disease progression following standard antitumor therapy or be unable or unwilling to receive standard treatments. Patients in the combination therapy group are suitable for PD-1 blockers therapy judged by the investigator .
- Patients must hava at least one measureble disease per RECIST 1.1.
- Patients must have a fresh tumor lession sample for sequencing and test of expression of PD-1(22c3,only for patients in the combination therapy group .)
- ECOG performance status of 0 or 1
Key exclusion criteria (16 listed)
- Having active malignant tumors within 2 years before the first administration, except for any locally curable tumors that have received radical treatment (e.g., resected basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix or breast);
- Presecne of central nervous system metastases, carcinomatous meningitis, or primary central nervous system tumors.
- Results of predicted neoantigen epitopes is less than 5.
- Having received other anti-tumor treatments (such as chemotherapy, endocrine therapy, targeted therapy, immunotherapy, radiotherapy, or tumor embolization) within 4 weeks before the first vaccination; for oral fluoropyrimidines and small-molecule targeted drugs, the interval required is more than 2 weeks or 5 half-lives of the drug, whichever is longer.
- Clinically significant residual toxicity (≥ grade 2 per CTCAE v5.0) from previous treatment (including systemic therapy, radiotherapy, or surgery), except for alopecia, hyperpigmentation, or other AEs deemed by the investigator not to affect study safety and where recovery to grade ≤1 is not required.
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 |
|---|---|---|
| personalized neoantigen mRNA tumor vaccineRH125 is a personalized neoantigen mRNA tumor vaccine which is constructed based on the results of patients' neoantigen sequencing. | Biological | escalation doses between 100μg, 150μg or 200μg of RH125 with or withoout PD-1 blockers |
Primary outcome
Percentage of Participants with Dose-Limiting Toxicities (DLT)
Time frame: From Day 1 to Day 21 after the first dose
Number of Participants with Adverse Events per CTCAE 5.0
Time frame: Up to approximately 24 months
Immunogenicity of a personalized cancer vaccine as measured by interferon-γ secreting T lymphocytes in peripheral blood mononuclear cells (PBMCs) using ELISpot
Time frame: Up to approximately 24 months
Serious adverse events as graded by CTCAE v5.0
Time frame: Up to approximately 24 months
adverse event of special interest as graded by CTCAE v5.0
Time frame: Up to approximately 24 months
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to approximately 24 months
Disease Control Rate(DCR)
Time frame: Up to approximately 24 months
Rime to response(TTR)
Time frame: Up to approximately 24 months
Duration of Response(DoR)
Time frame: Up to approximately 24 months
Progression Free Survival(PFS)
Time frame: Up to approximately 24 months
Overall Survival(OS)
Time frame: Up to 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 19 Sep 2025.
- 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.
Binghe Xu principal investigator
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Jianhua Chang principal investigator
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
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 personalized neoantigen mRNA tumor vaccine in people with Solid Tumor Malignancies, run by Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center 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 11 inclusion and 16 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 19 Sep 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 Jianhua Chang (+86-180-3816-8872, changjianhuacp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Dose-Limiting Toxicities (DLT) (time frame: From Day 1 to Day 21 after the first dose). The study lists 5 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 19 Sep 2025.