EVM16 Injection as a Single and Combination With Tislelizumab in Solid Tumors
ConditionAdvanced or Recurrent Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University
About this trial
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
Qualifiers
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
Disqualifiers
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).
Trial design
Treatments tested in this trial
- EVM16
- Tislelizumab
Treatment groups
78 Participants
are divided into 4 treatment groupsSponsors and collaborators
Peking University
Lead sponsor
Peking University Cancer Hospital & Institute
Sponsor institution
Shanghai Cancer Centre
Collaborator
Everest Medicines (China) Co.,Ltd.
Collaborator
Source ClinicalTrials.gov