EVM16 injection combined with tislelizumab for advanced solid tumors

A Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Immunogenicity, and Initial Efficacy of EVM16 Injection As a Single and Combination with Tislelizumab in Subjects with Advanced or Recurrent Solid Tumors

This study is testing a new tumor vaccine called EVM16, both on its own and with another treatment, to see if it can help people with advanced solid tumors that haven't improved with standard therapies.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University (other)
• Drugs / interventions: tislelizumab
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT06541639 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of EVM16, a tumor vaccine, both alone and in combination with the anti-PD-1 antibody tislelizumab in patients with advanced or recurrent solid tumors who have not responded to standard treatments. The study will assess the side effects and determine the appropriate dosage of EVM16. Participants will be required to provide tumor tissue samples for the production of EVM16 and must have measurable lesions as defined by RECIST criteria.

Who should consider this trial

Good fit: Ideal candidates include patients with recurrent or metastatic solid tumors that are not amenable to surgery or local therapy and have failed prior standard therapies.

Not a fit: Patients with primary central nervous system malignancies or uncontrolled co-morbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have exhausted standard treatment options.

How similar studies have performed: Other studies involving tumor vaccines and immune checkpoint inhibitors have shown promise, suggesting potential for success in this approach.

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.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Lin Shen, MD — Peking University Cancer Hospital & Institute
• Study coordinator: Lin Shen, MD

Conditions: Advanced or Recurrent Solid Tumors, solid tumor, tumor vaccine, immune checkpoint inhibitor