Recruiting
Phase 1
EVM16 Injection as a Single and Combination With Tislelizumab in Solid Tumors
Condition(s) studied
Advanced or Recurrent Solid Tumors
Investigational drug(s) / intervention(s)
EVM16: cancer vaccine
Tislelizumab: Anti-PD1 antibody
Study 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
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.
Primary outcome measure(s)
- safety and tolerability — From the first study intervention to 90 days after the last study intervention.
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs), the incidence of dose-limiting toxicity (DLT) (only in phase Ia), and the incidence of AEs of grade 3 or higher were assessed according to the NCI CTCAE v5.0 in the treatment of EVM16 alone as well as EVM16 in combination with Tislelizumab.
- RP2D for EVM16 — During the intervention, up to approximately 1 year.
Based on safety, tolerability, immunogenicity to determine RP2D.
Trial sites (2)
| Facility | City | Region | Status |
| Beijing Cancer Hospital |
Beijing |
Beijing Municipality |
Recruiting |
| Fudan University Shanghai Cancer Center |
Shanghai |
Shanghai Municipality |
Recruiting |
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