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EVM16 Injection as a Single and Combination With Tislelizumab in Solid Tumors

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Peking University

Status and phase

Not yet enrolling
Early Phase 1

Conditions

Advanced or Recurrent Solid Tumors

Treatments

Biological: EVM16
Drug: Tislelizumab

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06541639
EVM16CX01

Details and patient eligibility

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

78 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age ≥ 18 years on the day of signing the informed consent form.

  2. 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.

  3. 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.

  4. Patients with advanced or recurrent solid tumors who have failed prior standard therapy or are intolerant of standard therapy.

  5. Expected survival period >12 weeks.

  6. 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.

  7. Eastern Cooperative Oncology Group (ECOG) Physical Status Score 0 to 1.

  8. Subjects with hepatitis B virus (HBV) infection must have HBV DNA <2000 IU/mL at Screening.

  9. Subjects with a history of hepatitis C virus (HCV) infection (HCV antibody positive) who are also HCV RNA negative are permitted to be recruited.

  10. 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

  1. Other malignant tumors within 5 years prior to the first dose, except for the following:

    1. Tumors that have undergone radical treatment and have been definitively cured, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, thyroid carcinoma, adenocarcinoma in situ of the lung, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast;
    2. Second primary cancer that has been eradicated and has not recurred within five years.
  2. Primary central nervous system (CNS) malignancies that are symptomatic, untreated, or in need of curative treatment, or subjects with CNS metastases.

  3. 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.

  4. Cerebrovascular event (stroke, transient ischemic attack, etc.) within 4 months prior to the signing of inform consent form.

  5. In screening period male QTcF interval >450 ms; Female QTcF interval >470 ms (calculated by the Fridericia formula).

  6. Left ventricular ejection fraction (LVEF) < 50% during the screening period.

  7. 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).

  8. 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.

  9. Subjects with a history of positive human immunodeficiency virus (HIV) test or acquired immunodeficiency syndrome (AIDS).

  10. Co-infection HBV and HCV.

  11. Presence of any active infection requiring systemic therapy.

  12. Patients who are still on any other investigation medications treatment at the time of screening.

  13. 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.

  14. Previous treatment with cell therapy (e.g., TCR-T, CAR-T, TIL, etc.), tumor vaccines, cytokines, or growth factors for cancer control.

  15. Patients with prior intolerance to tislelizumab resulting in permanent termination of tislelizumab.

  16. Women who are pregnant or breastfeeding.

  17. 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:

  18. 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

78 participants in 4 patient groups

EVM 0.1mg
Experimental group
Description:
EVM16 0.1mg Q2W for 2 cycles, then EVM16 0.1mg Q3W combined with tislelizumab (anti-PD1 antibody) 200mg Q3W for 7 cycles.
Treatment:
Drug: Tislelizumab
Biological: EVM16
EVM 0.3mg
Experimental group
Description:
EVM16 0.3mg Q2W for 2 cycles, then EVM 0.3mg Q3W combined with tislelizumab (anti-PD1 antibody) 200mg Q3W for 7 cycles.
Treatment:
Drug: Tislelizumab
Biological: EVM16
EVM 1.0mg
Experimental group
Description:
EVM16 1.0mg Q2W for 2 cycles, then EVM 1.0mg Q3W combined with tislelizumab (anti-PD1 antibody) 200mg Q3W for 7 cycles.
Treatment:
Drug: Tislelizumab
Biological: EVM16
EVM RP2D
Experimental group
Description:
EVM16 RP2D Q3W combined with tislelizumab (anti-PD1 antibody) 200mg Q3W for 9 cycles.
Treatment:
Drug: Tislelizumab
Biological: EVM16

Trial contacts and locations

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Central trial contact

Lin Shen, MD; Yanshuo Cao, MD

Data sourced from clinicaltrials.gov

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