Advanced or Recurrent Solid TumorsPhase 1NCT06541639
EVM16 Injection as a Single and Combination With Tislelizumab in Solid Tumors
A Phase 1 study testing EVM16 and Tislelizumab in people with Advanced or Recurrent Solid Tumors, run by Peking University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Recurrent Solid Tumors
- What is being tested?
- EVM16 and Tislelizumab
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesChina
- Study dates
- 4 Mar 2025to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, +8601088196561, linshenpkn@163.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200135
Jian Zhang, +8602164175590, syner2000@163.com
About this study
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
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.
- Conditions
- Advanced or Recurrent Solid Tumors
- Being tested
- EVM16, Tislelizumab
- Keywords
- solid tumor, tumor vaccine, immune checkpoint inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVM16Biological
cancer vaccine
TislelizumabDrug
Also called Tevimbra
Anti-PD1 antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Level 1 | Experimental | EVM16 dose level 1 as single and combined therapy with Tislelizumab. Receives: Biological: EVM16; Drug: Tislelizumab |
| Dose Escalation Level 2 | Experimental | EVM16 dose level 2 as single and combined therapy with Tislelizumab. Receives: Biological: EVM16; Drug: Tislelizumab |
| Dose Escalation Level 3 | Experimental | EVM16 dose level 3 as single and combined therapy with Tislelizumab. Receives: Biological: EVM16; Drug: Tislelizumab |
| Dose Expansion | Experimental | EVM16 RP2D dose in combination with Tislelizumab. Receives: Biological: EVM16; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability
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.
Measured: From the first study intervention to 90 days after the last study intervention.
RP2D for EVM16
Based on safety, tolerability, immunogenicity to determine RP2D.
Measured: During the intervention, up to approximately 1 year.
Secondary outcomes (6)
immunogenicity of EVM16
Based on proportion of IFN-γ-positive T cells and/or T cell receptor sequences after EVM16 administration to assess the immunogenicity of EVM16 in subjects with advanced or recurrent solid tumours.
Measured: during the intervention, up to 1 year
objective response rate (ORR) of EVM16 in combination with tislelizumab
Proportion of patients with partial response (PR) and complete response (CR) as assessed by the investigators according to RECIST v1.1 in EVM16 combined with tislelizumab arm.
Measured: 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
Proportion of patients with partial response (PR) , complete response (CR) and stable disease (SD) as assessed by the investigators according to RECIST v1.1 in EVM16 combined with tislelizumab arm.
Measured: 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
Duration of objective response (PR and CR) as assessed by the investigators according to RECIST v1.1 in EVM16 combined with tislelizumab arm.
Measured: 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 from enrollment to objective response (PR and CR) as assessed by the investigators according to RECIST v1.1 in EVM16 combined with tislelizumab arm.
Measured: 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）
Progression-free survival (PFS) as assessed by the investigators according to RECIST v1.1 in EVM16 combined with tislelizumab arm.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start4 Mar 2025
- Primary completionMar 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Recurrent Solid TumorsStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Cancer Centre, Everest Medicines (China) Co.,Ltd.
- Responsible party
- Principal investigator, Shen Lin, Peking University Cancer Hospital & Institute
- Investigators
- Lin Shen, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541639
- Sponsor's protocol ID
- EVM16CX01
- Status last verified
- Jun 2026
- First submitted
- 29 Jul 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06541639
- Acronym / sponsor ID
- EVM16CX01
- Conditions
- Advanced or Recurrent Solid Tumors
- Keywords
- solid tumor, tumor vaccine, immune checkpoint inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Shanghai Cancer Centre, Everest Medicines (China) Co.,Ltd.
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Level 1 | Experimental | Biological: EVM16, Drug: TislelizumabEVM16 dose level 1 as single and combined therapy with Tislelizumab. |
| Dose Escalation Level 2 | Experimental | Biological: EVM16, Drug: TislelizumabEVM16 dose level 2 as single and combined therapy with Tislelizumab. |
| Dose Escalation Level 3 | Experimental | Biological: EVM16, Drug: TislelizumabEVM16 dose level 3 as single and combined therapy with Tislelizumab. |
| Dose Expansion | Experimental | Biological: EVM16, Drug: TislelizumabEVM16 RP2D dose in combination with Tislelizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVM16cancer vaccine | Biological | Dose Escalation Level 1, Dose Escalation Level 2, Dose Escalation Level 3, Dose Expansion |
| TislelizumabAlso: TevimbraAnti-PD1 antibody | Drug | Dose Escalation Level 1, Dose Escalation Level 2, Dose Escalation Level 3, Dose Expansion |
Primary outcome
safety and tolerability
Time frame: 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
Time frame: During the intervention, up to approximately 1 year.
Based on safety, tolerability, immunogenicity to determine RP2D.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lin Shen, MD principal investigator
Peking University Cancer Hospital & Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EVM16 and Tislelizumab in people with Advanced or Recurrent Solid Tumors, run by Peking University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin Shen, MD (+8601088196561, linshenpkn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and tolerability (time frame: From the first study intervention to 90 days after the last study intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.