EVM16 Injection as a Single and Combination With Tislelizumab in Solid Tumors (NCT06541639) | Clinical Trial Compass
RecruitingPhase 1
EVM16 Injection as a Single and Combination With Tislelizumab in Solid Tumors
China78 participantsStarted 2025-03-04
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Su…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
safety and tolerability
Timeframe: From the first study intervention to 90 days after the last study intervention.
2
RP2D for EVM16
Timeframe: During the intervention, up to approximately 1 year.