Clinical trial NCT06541639: EVM16 Injection As a Single and Combination with Tislelizumab in Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced or Recurrent Solid Tumors
Keywords: solid tumor
tumor vaccine
immune checkpoint inhibitor
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Shanghai Cancer Centre
name: Everest Medicines (China) Co.,Ltd.
First posted: 2024-08-07
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: safety and tolerability
timeFrame: From the first study intervention to 90 days after the last study intervention.
measure: RP2D for EVM16
timeFrame: During the intervention, up to approximately 1 year.
Secondary outcomes:
measure: immunogenicity of EVM16
timeFrame: during the intervention, up to 1 year
measure: objective response rate (ORR) of EVM16 in combination with tislelizumab
timeFrame: 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.
measure: disease control rate (DCR) of EVM16 in combination with tislelizumab
timeFrame: 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.
measure: duration of disease remission (DOR) of EVM16 in combination with tislelizumab
timeFrame: 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.
measure: time to remission (TTR) of EVM16 in combination with tislelizumab
timeFrame: 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.
measure: PFS of EVM16 in combination with tislelizumab （Only in phase Ib）
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Lin Shen, MD
role: PRINCIPAL_INVESTIGATOR
References: