Malignant solid tumors at high risk of recurrence after radical treatment
Conditions
Interventions
Increase the dose of single-drug treatment:Accelerated titration combined with Bayesian optimal interval (BOIN) design was adopted to guide dose escalation
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) The subjects should understand and abide by the relevant procedures of the research and voluntarily sign the premarital consent form. 2) Age: 18 to 75 years old (including the boundary value), gender not limited; 3) Malignant solid tumors confirmed by histology or cytology. 4) For malignant tumors with a high risk of recurrence after radical mastectomy, researchers refer to the 8th edition of the AJCC guidelines to determine the clinical stage and assess high-risk recurrence risk factors, such as a relatively late T stage due to large tumor volume or deep invasion, positive N stage due to regional lymph node metastasis, and potential metastasis risks such as invasion of blood vessels, nerve bundles or vascular tumor thrombecs. 5) Those who have completed standard adjuvant therapy after radical resection; If there is no standard adjuvant therapy, or the subject is intolerant to adjuvant therapy, or the researcher determines that the subject is not suitable for standard adjuvant therapy, the reasons need to be recorded in the medical record. Adjuvant therapy intolerance refers to the situation where a subject is unable to continue receiving adjuvant therapy due to treatment-related toxicity during the adjuvant therapy period. "Unsuitability for standard adjuvant therapy refers to the situation where researchers, after a comprehensive assessment of the subject's general condition, liver and kidney functions, etc., determine that the subject is not suitable for standard adjuvant therapy." 6) No evidence of disease recurrence: Imaging examinations show no recurrence or metastasis. 7) Eastern Cooperative Oncology Group (ECOG) Performance Status Score: 0 or 1 point; 8) The functions of vital organs meet the following criteria (no blood components or cell growth factors have been used within 14 days prior to the start of the study and treatment) : a) Blood routine: Neutrophil count (ANC) >= 1.5×10^9/L, lymphocyte count (LYM) >= 0.5×10^9/L, platelet count (PLT) >= 1× lower limit of normal (LLN), hemoglobin (Hb) >= 90g/L; b) Blood biochemistry: Total bilirubin (TBIL) = 30g/L, serum creatinine (Scr) = 50%; e) Electrocardiogram: QT interval (QTcF) corrected by the Fridericia method <470 milliseconds; The QTc interval must be corrected according to Fridericia's standard, with the correction formula QTcF=QT/RR^0.33. 9) Female subjects with fertility must undergo a serum pregnancy test within 7 days before the first dose of the vaccine, and the result must be negative, and they must not be in the lactation period. 10) Fertile female subjects and male subjects whose partners are women of childbearing age must agree to comply with contraceptive requirements from the signing of the premarital consent form until 6 months after the end of the last treatment.
Exclusion criteria
Exclusion criteria: 1) Received immune cell or tumor vaccine treatment, including but not limited to tumor-infiltrating lymphocytes (TILs), chimeric antigen receptor T cells (CAR-T), T-cell receptor chimeric T cells (TCR-T), and therapeutic tumor vaccines, etc. 2) It is planned to receive live attenuated vaccines during the screening period or the study period and within 90 days after the end of the study drug treatment (inactivated vaccines are allowed). 3) Any individual who has been evaluated by the researcher as unsuitable for immunotherapy; 4) Those with autoimmune diseases (except for those with hypothyroidism caused by autoimmune thyroiditis that requires hormone replacement therapy); 5) NSCLC subjects have exon 19 deletion or exon 21 (L858R) replacement mutation of epidermal growth factor receptor (EGFR) and positive anaplastic lymphoma kinase (ALK). 6) There is a known history of epilepsy or other symptomatic neurological disorders; 7) There is a known history of abuse of psychotropic substances, alcohol abuse or drug use; 8) There is evidence of active tuberculosis infection within one year before the screening period and during the screening period, regardless of whether treatment has been received; 9) Subjects with known or suspected interstitial pneumonia, or those with evidence of interstitial pneumonia indicated by chest CT during the screening period; A history of idiopathic pulmonary fibrosis and organizing pneumonia (such as obliterative bronchiolitis or cryptogenic organizing pneumonia) is known. 10) History of other malignant tumors within 5 years prior to the screening period; 11) A known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 12) Known to be allergic to the research drug or any of its excipients, or have a history of severe allergic reactions to other vaccines; 13) Suffering from congenital or acquired immune deficiency Such as cellular immune deficiencies (such as DiGeorge syndrome, T-negative severe combined immune deficiency [SSCID]) or combined T-cell and B-cell immune deficiencies (such as T- and B-negative combined immune deficiency, Wiskott-Aldrich syndrome, ataxia telangiectasia, common variable immune deficiencies); Or people infected with the Human immunodeficiency virus (HIV); 14) Suffering from poorly controlled or severe cardiovascular and cerebrovascular diseases: such as symptomatic congestive heart failure (NYHA standard grade III or IV), severe arrhythmia requiring treatment or intervention, and hypertension (systolic blood pressure >= 160mmHg, diastolic blood pressure >= 100mmHg) that remains poorly controlled after adequate treatment; 15) Postoperative surgical complications have not recovered, or the complications are higher than Clavien-Dindo complication grade 2; 16) The toxicity caused by adjuvant therapy before the first vaccine administration has not returned to the baseline level or is > grade 1 (except for alopecia and pigmentation), and the neurotoxicity is > grade 2; 17) Severe infection occurs within 28 days before the first dose of the vaccine (such as intravenous infusion of antibiotics, antifungal or antiviral drugs as required by clinical diagnosis and treatment norms); 18) There is clinically uncontrolled pleural or ascites that requires thoracentesis or peritoneal puncture and drainage within 28 days before the first dose of the vaccine; 19) Active hepatitis B (defined as a positive result of active hepatitis B surface ant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerability of RGL-232 monotherapy in patients with malignant solid tumors; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) characteristics of RGL-232 monotherapy;The immunogenicity of RGL-232;The preliminary efficacy of RGL-232 in patients with malignant solid tumors; | — |
Countries
China
Contacts
Public ContactJihui Hao
Tianjin Medical University Cancer Institute and Hospital
Outcome results
None listed