Status and phase
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About
The goal of this clinical trial is to learn the side effects, safety and effect of a tumor vaccine (EVM16) alone or in combined with an anti-PD-1 antibody (tislelizumab) . This clinical trial will include solid tumor patients who failed standard treatment.
The main questions to answer are:
Safety of EVM16. Suitable dose of EVM16. Effects of EVM16 combined with tislelizumab.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age ≥ 18 years on the day of signing the informed consent form.
Subjects can understand and voluntarily sign the informed consent form, including adherence to the requirements and limitations outlined in the Informed Consent Form (ICF) and protocol.
Recurrent or metastatic solid tumors that have been histologically or cytologically pathologically confirmed and are not amenable to radical treatment with surgery or local therapy.
Patients with advanced or recurrent solid tumors who have failed prior standard therapy or are intolerant of standard therapy.
Expected survival period >12 weeks.
Patients must have adequate organ function as indicated by the following laboratory test values:
Organ system Laboratory test values
WBC ≥3× 10^9 /L; ANC ≥1.5 × 10^9 /L; Platelet ≥90 × 10^9 /L; Hemoglobin ≥90 g/L;
Renal Function:
Serum creatinine≤1.5 × upper limit of normal (ULN) and calculated creatinine clearance (CrCL) >60 mL/min (Cockcroft-Gault formula).
Liver function:
Total bilirubin（TBIL）≤1.5 × ULN, or ≤3 × ULN（in patients with known Gilbert's disease); AST (SGOT) and ALT (SGPT) ≤2.5 × ULN, or ≤5 × ULN (patients with liver metastases or HCC); Serum albumin≥30 g/L.
Coagulation function:
INR and PT≤1.5 × ULN; APTT≤1.5 × ULN.
Eastern Cooperative Oncology Group (ECOG) Physical Status Score 0 to 1.
Subjects with hepatitis B virus (HBV) infection must have HBV DNA <2000 IU/mL at Screening.
Subjects with a history of hepatitis C virus (HCV) infection (HCV antibody positive) who are also HCV RNA negative are permitted to be recruited.
Women of childbearing potential must have a negative pregnancy test result within ≤ 7 days prior to the first dose of the test drug. Women of childbearing potential include premenopausal females and females who are menopausal and within 2 years of their last menstrual period. Female subjects of childbearing potential or male subjects and their female partners of childbearing potential must agree to use effective contraception from the time of sign off informed consent form until at least 180 days after completion of study treatment.
Exclusion criteria
Other malignant tumors within 5 years prior to the first dose, except for the following:
Primary central nervous system (CNS) malignancies that are symptomatic, untreated, or in need of curative treatment, or subjects with CNS metastases.
Uncontrolled co-morbidities including, but not limited to, medically poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg) and medically poorly controlled type 2 diabetes mellitus (fasting blood glucose ≥ 8.9 mmol/L), or other serious disease requiring systemic therapy. Active gastric or duodenal ulcer.
Cerebrovascular event (stroke, transient ischemic attack, etc.) within 4 months prior to the signing of inform consent form.
In screening period male QTcF interval >450 ms; Female QTcF interval >470 ms (calculated by the Fridericia formula).
Left ventricular ejection fraction (LVEF) < 50% during the screening period.
Diagnosis of immunodeficiency, or history or syndrome of active as well as former autoimmune disease with risk of relapse (e.g., organ transplant requiring immunosuppressive therapy), or a disease requiring systemic steroid hormone (prednisone equivalents >10 mg per day) or immunosuppressive drug therapy. However, except for subjects with type I diabetes mellitus requiring only stable doses of insulin replacement therapy, hypothyroidism that is stabilized on hormone replacement therapy, or skin disorders that do not require systemic therapy (e.g., vitiligo, alopecia areata, psoriasis, or eczema).
Known peripheral edema, pericardial effusion, pleural effusion, or ascites during the Screening Period requiring medical intervention, or limiting activities of daily living, or clinically symptomatic or a known history of peripheral vascular disease including, but not limited to, macrovascular disease and microangiopathy secondary to diabetes mellitus, peripheral arteriopathy of any cause, intermittent claudication, recurrent and/or non-healing ulcers of any cause.
Subjects with a history of positive human immunodeficiency virus (HIV) test or acquired immunodeficiency syndrome (AIDS).
Co-infection HBV and HCV.
Presence of any active infection requiring systemic therapy.
Patients who are still on any other investigation medications treatment at the time of screening.
The severity of any toxic event has not been reduced to ≤ grade 1 under the NCI-CTCAE version 5.0 definition from previous treatment such as drug therapy, radiotherapy, or surgical manipulation.
Previous treatment with cell therapy (e.g., TCR-T, CAR-T, TIL, etc.), tumor vaccines, cytokines, or growth factors for cancer control.
Patients with prior intolerance to tislelizumab resulting in permanent termination of tislelizumab.
Women who are pregnant or breastfeeding.
Any disease or condition that, in the opinion of the investigator, would compromise the safety of the subject or interfere with study assessments.
Applies to second clinical screening only:
History or presence of significant lung disease, such as uncontrolled chronic lung disease; history or evidence of any ≥ grade 2 interstitial lung disease (ILD); enrollment in grade 1 interstitial lung disease (ILD) is determined by the investigator after a comprehensive judgment based on the risk-benefit and the impact of the AE assessment related to the study treatment; and has the potential to interfere with the evaluation or management of pulmonary toxicity related to the study treatment.
Primary purpose
Allocation
Interventional model
Masking
78 participants in 4 patient groups
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Central trial contact
Lin Shen, MD; Yanshuo Cao, MD
Data sourced from clinicaltrials.gov
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