Selected Types of Solid TumorPhase 1/2NCT07095868
Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 Alone and in Combination in Patients With Selected Solid Tumors
A Phase 1/2 study testing EVM14 and Pembrolizumab in people with Selected Types of Solid Tumor, run by Everest Medicines (Beijing) Co., Ltd. at 7 sites in 2 countries.
Trial summary
Brief Summary: The purpose of this clinical trial is to evaluate the safety, tolerability, preliminary efficacy, and immunogenicity of EVM14 administered intramuscularly (IM) alone and in combination with pembrolizumab in patients with selected solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Selected Types of Solid Tumor
- What is being tested?
- EVM14 and Pembrolizumab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 17 Nov 2025to Nov 2031
- Phase
- Phase 1/2
- 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
- Selected types of solid tumor that are pathologically confirmed unresectable advanced, recurrent, or metastatic.
- Patients with at least 1 evaluable lesion assessed by Investigators within 28 days prior to the first dose of study treatment as defined per RECIST v1.1.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 at Screening.
- Life expectancy ≥ 3 months.
- Patients must have adequate organ function.
- At screening, patients must agree to provide, if available, tumor tissue for biomarker analysis. When archival tumor tissue is not available, it is optional for the patient to undergo a fresh biopsy to collect tumor tissue if deemed medically safe by the Investigator.
Who cannot join
- Has disease that is suitable for local treatment administered with curative intent.
- Has a diagnosed and/or treated additional malignancy within 5 years prior to the first dose of study treatment except for: curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, and curatively resected in situ breast, cervical cancer, and prostate cancer.
- Histologically/cytologically confirmed nasopharynx cancer. Has non-squamous histology NSCLC. If small cell elements are present, the patient is ineligible.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has a diagnosis of immunodeficiency.
- Use of systemic corticosteroid (> 10 mg/day prednisone or equivalent) or other immunosuppressive medication within 14 days before the first dose of study treatment.
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- Has active autoimmune disease that has required systemic treatment in past 2 years or history of autoimmune disease that has possibility of relapse or at risk of having these conditions.
- Poorly controlled co-morbidity, including but not limited to poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg) and poorly controlled type 2 diabetes, or other serious conditions requiring systemic treatment. Active gastric or duodenal ulcer.
- Cerebrovascular events (stroke, transient ischemic attack, etc.) within 6 months prior to the first dose of study treatment.
- QTcF interval male > 450 msec; female > 470 msec Or serious cardiovascular disease within 6 months prior to the first dose of study treatment
- The left ventricular ejection fraction (LVEF) < 50% during the screening period.
- History of Stevens-Johnson syndrome or toxic epidermal necrolysis syndrome.
- Patients known to be human immunodeficiency virus (HIV)-positive or have acquired immune deficiency syndrome (AIDS).
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
China4 sites, 4 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410006
Hui Wang, 86 0731 8976 2900, wanghui@hnca.org.cn
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
Mi Yang, 86 025 8310 6666, yangmi@nju.edu.cn
- Recruiting
The First Affiliated Hospital With Nanjing Medical University
Nanjing, Jiangsu, 210029
Renhua Guo, guorenhua@csco.ac.cn
86 25 8621 1033
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Shengxiang Ren, 86 21 6511 5006, harry_ren@126.com
United States3 sites, 3 recruiting
- Recruiting
NEXT Oncology
Fairfax, Virginia, 22031
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10022
spenceg1@mskcc.org
About this study
Official title: A Phase I/IIa Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Solid Tumors
Brief Summary:
The purpose of this clinical trial is to evaluate the safety, tolerability, preliminary efficacy, and immunogenicity of EVM14 administered intramuscularly (IM) alone and in combination with pembrolizumab in patients with selected solid tumors.
Read the detailed description
EVM14C101 study is a First in Human(FIH), open-label, multiregional, multicenter study conducted in 2 Phases: Phase I and Phase IIa. In Phase I, EVM14 will be administered intramuscularly(IM) as a monotherapy (Mono Cohort) and in combination with pembrolizumab (Combo Cohort) in patients with solid tumors to assess the safety and tolerability, immunogenicity, preliminary efficacy of EVM14 as monotherapy and in combination with pembrolizumab. Based on the safety and immunogenicity data of Phase I, dose of EVM14 will be selected for the Phase IIa. In Phase IIa, the safety and tolerability, preliminary efficacy, and immunogenicity of EVM14 in combination with pembrolizumab will be further assessed in patients with solid tumors.
- Conditions
- Selected Types of Solid Tumor
- Being tested
- EVM14, Pembrolizumab
- Keywords
- Solid Tumor, Cancer Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVM14Biological
Cancer Vaccine
PembrolizumabCombination product
Anti-PD1 antibody
| Study group | Role | What they receive |
|---|---|---|
| Phase I Dose Escalation in Monotherapy Cohort | Experimental | Not described Receives: Biological: EVM14 |
| Phase I Dose Escalation in Combination Therapy Cohort | Experimental | Not described Receives: Biological: EVM14; Combination Product: Pembrolizumab |
| Phase IIa Dose Level A for tumor type 1 | Experimental | Not described Receives: Biological: EVM14; Combination Product: Pembrolizumab |
| Phase IIa Dose Level B for tumor type 1 | Experimental | Not described Receives: Biological: EVM14; Combination Product: Pembrolizumab |
| Phase IIa Control arm for tumor type 1 | Active comparator | Not described Receives: Combination Product: Pembrolizumab |
| Phase IIa Combo therapy for tumor type 2 | Experimental | Not described Receives: Biological: EVM14; Combination Product: Pembrolizumab |
| Phase IIa Control for tumor type 2 | Active comparator | For patients with tumor type 2, pembrolizumab 200 mg alone will be administered intravenously (IV infusion) every 3 weeks (Q3W) if disease progression doesn't occur. Receives: Combination Product: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I and Phase IIa: Incidence and severity of adverse events
Measured: From the the start of the first dose of study treatment to 90 days after the last study treatment or new anti-cancer treatments started, whichever occurs earlier.
Phase I: Incidence of dose-limiting toxicities (DLT)
Measured: Mono cohort: 28-day period from the first EVM14 monotherapy dose. Combo cohort: Days 1 to 21: 21-day period from the first dose of EVM14 in combination with pembrolizumab.
Phase IIa tumor type 1: Progression-free survival (PFS)
The time from date of randomization to the first documented disease progression per RECIST 1.1 evaluated by Investigators or death due to any cause, whichever occurs first.
Measured: From the baseline to disease progression confirmed by radiological examination, the start of a new anti-cancer treatment, withdrawal of informed consent, lost to follow-up, death, or end of study, whichever occurs first. (Up to 3 years)
Secondary outcomes (5)
Phase I and Phase IIa: Objective response rate (ORR)
The percentage of patients meeting the criteria of best overall response as complete response (CR) or partial response (PR) evaluated by Investigators based on RECIST v1.1.
Measured: From the baseline to disease progression confirmed by radiological examination, the start of a new anti-cancer treatment, withdrawal of informed consent, lost to follow-up, death, or end of study, whichever occurs first. (Up to 3 years.)
Phase I and Phase IIa: Disease control rate (DCR)
The percentage of patients meeting criteria of best overall response as stable disease (SD), PR, or CR evaluated by Investigators based on RECIST v1.1.
Measured: From the baseline to disease progression confirmed by radiological examination, the start of a new anti-cancer treatment, withdrawal of informed consent, lost to follow-up, death, or end of study, whichever occurs first. (Up to 3 years.)
Phase I and Phase IIa: Duration of response (DOR)
The time between the date of earliest determination of CR or PR to the date of earliest documented progressive disease (PD), or to the date of death due to any cause, whichever occurs first.
Measured: From the baseline to disease progression confirmed by radiological examination, the start of a new anti-cancer treatment, withdrawal of informed consent, lost to follow-up, death, or end of study, whichever occurs first. (Up to 3 years.)
Phase I and Phase IIa tumor type 2: Progression Free Survival (PFS)
The time from date of randomization or date of first dose to the first documented disease progression per RECIST 1.1 evaluated by Investigators or death due to any cause, whichever occurs first.
Measured: From the baseline to disease progression confirmed by radiological examination, the start of a new anti-cancer treatment, withdrawal of informed consent, lost to follow-up, death, or end of study, whichever occurs first. (Up to 3 years.)
Phase IIa: Time to response (TTR)
The time between date of randomization/first dose and the date of first PR or CR.
Measured: From the baseline to disease progression confirmed by radiological examination, the start of a new anti-cancer treatment, withdrawal of informed consent, lost to follow-up, death, or end of study, whichever occurs first. (Up to 3 years.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start17 Nov 2025
- Primary completionNov 2029 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Selected Types of Solid TumorStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Everest Medicines (Beijing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095868
- Sponsor's protocol ID
- EVM14C101
- Status last verified
- May 2026
- First submitted
- 24 Jul 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of EVM14 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Solid Tumors
- ClinicalTrials.gov ID
- NCT07095868
- Acronym / sponsor ID
- EVM14C101
- Conditions
- Selected Types of Solid Tumor
- Keywords
- Solid Tumor, Cancer Vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Everest Medicines (Beijing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 31 Jul 2025 (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.
Brief Summary:
The purpose of this clinical trial is to evaluate the safety, tolerability, preliminary efficacy, and immunogenicity of EVM14 administered intramuscularly (IM) alone and in combination with pembrolizumab in patients with selected solid tumors.
Detailed description
EVM14C101 study is a First in Human(FIH), open-label, multiregional, multicenter study conducted in 2 Phases: Phase I and Phase IIa. In Phase I, EVM14 will be administered intramuscularly(IM) as a monotherapy (Mono Cohort) and in combination with pembrolizumab (Combo Cohort) in patients with solid tumors to assess the safety and tolerability, immunogenicity, preliminary efficacy of EVM14 as monotherapy and in combination with pembrolizumab. Based on the safety and immunogenicity data of Phase I, dose of EVM14 will be selected for the Phase IIa. In Phase IIa, the safety and tolerability, preliminary efficacy, and immunogenicity of EVM14 in combination with pembrolizumab will be further assessed in patients with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Phase I Dose Escalation in Monotherapy Cohort | Experimental | Biological: EVM14 |
| Phase I Dose Escalation in Combination Therapy Cohort | Experimental | Biological: EVM14, Combination Product: Pembrolizumab |
| Phase IIa Dose Level A for tumor type 1 | Experimental | Biological: EVM14, Combination Product: Pembrolizumab |
| Phase IIa Dose Level B for tumor type 1 | Experimental | Biological: EVM14, Combination Product: Pembrolizumab |
| Phase IIa Control arm for tumor type 1 | Active comparator | Combination Product: Pembrolizumab |
| Phase IIa Combo therapy for tumor type 2 | Experimental | Biological: EVM14, Combination Product: Pembrolizumab |
| Phase IIa Control for tumor type 2 | Active comparator | Combination Product: PembrolizumabFor patients with tumor type 2, pembrolizumab 200 mg alone will be administered intravenously (IV infusion) every 3 weeks (Q3W) if disease progression doesn't occur. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Selected types of solid tumor that are pathologically confirmed unresectable advanced, recurrent, or metastatic.
- Patients with at least 1 evaluable lesion assessed by Investigators within 28 days prior to the first dose of study treatment as defined per RECIST v1.1.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 at Screening.
- Life expectancy ≥ 3 months.
- Patients must have adequate organ function.
Key exclusion criteria (13 listed)
- Has disease that is suitable for local treatment administered with curative intent.
- Has a diagnosed and/or treated additional malignancy within 5 years prior to the first dose of study treatment except for: curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, and curatively resected in situ breast, cervical cancer, and prostate cancer.
- Histologically/cytologically confirmed nasopharynx cancer. Has non-squamous histology NSCLC. If small cell elements are present, the patient is ineligible.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has a diagnosis of immunodeficiency.
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 |
|---|---|---|
| EVM14Cancer Vaccine | Biological | Phase I Dose Escalation in Combination Therapy Cohort, Phase I Dose Escalation in Monotherapy Cohort, Phase IIa Combo therapy for tumor type 2, Phase IIa Dose Level A for tumor type 1, Phase IIa Dose Level B for tumor type 1 |
| PembrolizumabAnti-PD1 antibody | Combination product | Phase I Dose Escalation in Combination Therapy Cohort, Phase IIa Combo therapy for tumor type 2, Phase IIa Control arm for tumor type 1, Phase IIa Control for tumor type 2, Phase IIa Dose Level A for tumor type 1, Phase IIa Dose Level B for tumor type 1 |
Primary outcome
Phase I and Phase IIa: Incidence and severity of adverse events
Time frame: From the the start of the first dose of study treatment to 90 days after the last study treatment or new anti-cancer treatments started, whichever occurs earlier.
Phase I: Incidence of dose-limiting toxicities (DLT)
Time frame: Mono cohort: 28-day period from the first EVM14 monotherapy dose. Combo cohort: Days 1 to 21: 21-day period from the first dose of EVM14 in combination with pembrolizumab.
Phase IIa tumor type 1: Progression-free survival (PFS)
Time frame: From the baseline to disease progression confirmed by radiological examination, the start of a new anti-cancer treatment, withdrawal of informed consent, lost to follow-up, death, or end of study, whichever occurs first. (Up to 3 years)
The time from date of randomization to the first documented disease progression per RECIST 1.1 evaluated by Investigators or death due to any cause, whichever occurs first.
5 secondary outcomes
Phase I and Phase IIa: Objective response rate (ORR)
Time frame: From the baseline to disease progression confirmed by radiological examination, the start of a new anti-cancer treatment, withdrawal of informed consent, lost to follow-up, death, or end of study, whichever occurs first. (Up to 3 years.)
Phase I and Phase IIa: Disease control rate (DCR)
Time frame: From the baseline to disease progression confirmed by radiological examination, the start of a new anti-cancer treatment, withdrawal of informed consent, lost to follow-up, death, or end of study, whichever occurs first. (Up to 3 years.)
Phase I and Phase IIa: Duration of response (DOR)
Time frame: From the baseline to disease progression confirmed by radiological examination, the start of a new anti-cancer treatment, withdrawal of informed consent, lost to follow-up, death, or end of study, whichever occurs first. (Up to 3 years.)
Phase I and Phase IIa tumor type 2: Progression Free Survival (PFS)
Time frame: From the baseline to disease progression confirmed by radiological examination, the start of a new anti-cancer treatment, withdrawal of informed consent, lost to follow-up, death, or end of study, whichever occurs first. (Up to 3 years.)
Phase IIa: Time to response (TTR)
Time frame: From the baseline to disease progression confirmed by radiological examination, the start of a new anti-cancer treatment, withdrawal of informed consent, lost to follow-up, death, or end of study, whichever occurs first. (Up to 3 years.)
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 4 Aug 2026.
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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.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EVM14 and Pembrolizumab in people with Selected Types of Solid Tumor, run by Everest Medicines (Beijing) Co., Ltd. at 7 sites in 2 countries.
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 6 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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China, United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Everest Clinical Trial Information Center (+86 21 8012 5712, ctinfo.center@everestmedicines.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I and Phase IIa: Incidence and severity of adverse events (time frame: From the the start of the first dose of study treatment to 90 days after the last study treatment or new anti-cancer treatments started, whichever occurs earlier.). The study lists 3 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 4 Aug 2026.