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.
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 .)
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.
Single group
personalized neoantigen mRNA tumor vaccine
Biological/VaccineRH125 is a personalized neoantigen mRNA tumor vaccine which is constructed based on the results of patients' neoantigen sequencing.
Percentage of Participants with Dose-Limiting Toxicities (DLT)
Number of Participants with Adverse Events per CTCAE 5.0
Immunogenicity of a personalized cancer vaccine as measured by interferon-γ secreting T lymphocytes in peripheral blood mononuclear cells (PBMCs) using ELISpot
Serious adverse events as graded by CTCAE v5.0
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.
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.
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.
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.
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