Exploratory Clinical Study of Personalized mRNA Tumor Vaccine RH125 in Patients With Advanced Solid Tumors

NCT07182435 | Not Yet Recruiting Early Phase 1

• 1 other identifier: RH125-0-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. The aim of the study is to evaluate the tolerability, safety, immunogenicity, and preliminary efficacy of RH125 monotherapy or combination with PD-1 blocker.

Conditions

Solid Tumor Malignancies

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants with Dose-Limiting Toxicities (DLT)

  From Day 1 to Day 21 after the first dose

• Number of Participants with Adverse Events per CTCAE 5.0

  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

  Up to approximately 24 months

• Serious adverse events as graded by CTCAE v5.0

  Up to approximately 24 months

• adverse event of special interest as graded by CTCAE v5.0

  Up to approximately 24 months

Secondary Outcomes (6)

• Objective Response Rate (ORR)

  Up to approximately 24 months

• Disease Control Rate(DCR)

  Up to approximately 24 months

• Rime to response(TTR)

  Up to approximately 24 months

• Duration of Response(DoR)

  Up to approximately 24 months

• Progression Free Survival(PFS)

  Up to approximately 24 months

Study Arms (1)

escalation doses between 100μg, 150μg or 200μg of RH125 with or withoout PD-1 blockers

EXPERIMENTAL

Biological: personalized neoantigen mRNA tumor vaccine

Interventions

personalized neoantigen mRNA tumor vaccine BIOLOGICAL

RH125 is a personalized neoantigen mRNA tumor vaccine which is constructed based on the results of patients' neoantigen sequencing.

escalation doses between 100μg, 150μg or 200μg of RH125 with or withoout PD-1 blockers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Adequate organ and hematologic function, with no severe dysfunction of the heart, lungs, liver, kidneys, or immune system, based on the following laboratory values:
• ). 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).
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, 518100, China

Location

Study Officials

• Binghe Xu

  Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

  PRINCIPAL INVESTIGATOR

• Jianhua Chang

  Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianhua Chang

CONTACT

+86-180-3816-8872; changjianhuacp@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 19, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)