EVM16 Injection As a Single and Combination with Tislelizumab in Solid Tumors

Launched by PEKING UNIVERSITY · Aug 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called EVM16, which is a tumor vaccine designed to help the body fight advanced or recurrent solid tumors that haven’t responded to standard treatments. The trial will also examine how well EVM16 works when combined with another medication called tislelizumab, which helps boost the immune system's ability to attack cancer cells. The main goals of the study are to understand the safety of EVM16, determine the best dose to use, and see how the combination with tislelizumab affects patients.

To participate in this trial, patients should have confirmed advanced or recurrent solid tumors that cannot be treated with surgery or other local therapies and have not responded to previous standard treatments. They should also expect to survive for more than six weeks, have adequate organ function, and be willing to provide tumor samples for research. Participants will be closely monitored for any side effects and overall health during the study. It’s important to note that certain health conditions may exclude individuals from joining, such as active infections or significant heart disease. Overall, this trial aims to explore new treatment options for patients facing challenging cancer diagnoses.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 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.
• • Expected survival period \>6 weeks at the time of informed consent.
• • Adequate organ function
• • Eastern Cooperative Oncology Group (ECOG) Physical Status Score 0 to 1.
• • Is willing to provide archival or fresh tumor tissue samples for EVM16 production.
• • Has adequate treatment washout period prior to first study dose.
• • Has at least one measurable lesion as assessed by the investigator according to RECIST version 1.1 criteria before enrollment.
• Key Exclusion Criteria:
• • Primary central nervous system (CNS) malignancies that are symptomatic, untreated, or in need of curative treatment, or subjects with CNS metastases.
• • Uncontrolled co-morbidities.
• • 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, or a disease requiring systemic steroid hormone or immunosuppressive drug therapy.
• • 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 investigational medications treatment at the time of screening.
• • Previous treatment with cell therapy, tumor vaccines, cytokines, or growth factors for cancer control.
• • Patients with prior intolerance to tislelizumab resulting in permanent termination of tislelizumab.
• • History or presence of significant lung disease.