Recruiting NCT06541639
EVM16 Injection as a Single and Combination With Tislelizumab in Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EVM16, Tislelizumab.
- Who it may be relevant to
- Registry conditions: Advanced or Recurrent Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Biological EVM16
cancer vaccine - Drug Tislelizumab
Anti-PD1 antibody
Primary outcome measures
- safety and tolerability [Time frame: From the first study intervention to 90 days after the last study intervention.]
- RP2D for EVM16 [Time frame: During the intervention, up to approximately 1 year.]
Secondary outcome measures (6)
- immunogenicity of EVM16 [Time frame: during the intervention, up to 1 year]
- objective response rate (ORR) of EVM16 in combination with tislelizumab [Time frame: From date of first study dose until the date of disease progression, or until the patient start subsequent anti-cancer treatment, or death, or lost to follow up or the study ends, whichever occurs first.]
- disease control rate (DCR) of EVM16 in combination with tislelizumab [Time frame: From date of first study dose until the date of disease progression, or until the patient start subsequent anti-cancer treatment, or death, or lost to follow up or the study ends, whichever occurs first.]
- duration of disease remission (DOR) of EVM16 in combination with tislelizumab [Time frame: From date of first study dose until the date of disease progression, or until the patient start subsequent anti-cancer treatment, or death, or lost to follow up or the study ends, whichever occurs first.]
- time to remission (TTR) of EVM16 in combination with tislelizumab [Time frame: From date of first study dose until the date of disease progression, or until the patient start subsequent anti-cancer treatment, or death, or lost to follow up or the study ends, whichever occurs first.]
- PFS of EVM16 in combination with tislelizumab （Only in phase Ib） [Time frame: From date of first study dose until the date of disease progression, or until the patient start subsequent anti-cancer treatment, or death, or lost to follow up or the study ends, whichever occurs first]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Beijing Cancer Hospital — Beijing
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT06541639 · EVM16CX01