New cancer vaccine aims to fight advanced tumors when other treatments fail
NCT ID NCT06541639
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a cancer vaccine called EVM16, either by itself or combined with an immune-boosting drug (tislelizumab), in people with advanced or recurrent solid tumors that have not responded to standard treatments. The main goals are to find a safe dose and see if the vaccine triggers an immune response against the cancer. The trial involves about 78 participants and will monitor side effects and any tumor shrinkage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- EVM16 (cancer vaccine) and tislelizumab (anti-PD-1 antibody)
- What this could lead to
- If successful, this approach could offer a new treatment option for people with advanced solid tumors who have run out of standard therapies.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the vaccine may not prove effective or may cause unexpected side effects. The results may not apply to all tumor types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 78 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Cancer Hospital
RECRUITINGBeijing, Beijing Municipality, 100142, China
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 200135, China
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