NCT06541639 EVM16 Injection As a Single and Combination with Tislelizumab in Solid Tumors
| NCT ID | NCT06541639 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Peking University |
| Condition | Advanced or Recurrent Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2025-03-04 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 78 participants in total. It began in 2025-03-04 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Lin Shen, MD
PRINCIPAL INVESTIGATOR
Peking University Cancer Hospital & Institute
Frequently Asked Questions
Who can join the NCT06541639 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced or Recurrent Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06541639 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06541639 currently recruiting?
Yes, NCT06541639 is actively recruiting participants. Contact the research team at linshenpkn@163.com for enrollment information.
Where is the NCT06541639 trial being conducted?
This trial is being conducted at Beijing, China, Shanghai, China.
Who is sponsoring the NCT06541639 clinical trial?
NCT06541639 is sponsored by Peking University. The principal investigator is Lin Shen, MD at Peking University Cancer Hospital & Institute. The trial plans to enroll 78 participants.