Advanced Malignant Solid TumorsNCT05949775
Clinical Study of mRNA Vaccine in Patients With Advanced Malignant Solid Tumors
A study testing Neoantigen mRNA Personalised Cancer vaccine in people with Advanced Malignant Solid Tumors, run by Stemirna Therapeutics.
Trial summary
This study is an open, single arm, dose increasing study to evaluate the safety and efficacy of the combination of mRNA personalized tumor vaccine encoding neoantigen (hereinafter referred to as tumor vaccine) and Sintilimab injection (hereinafter referred to as Sintilimab) in the treatment of advanced malignant solid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Tumors
- What is being tested?
- Neoantigen mRNA Personalised Cancer vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2023to 20 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Are ≥18 years old, without limitation of sex at time of consent.
- Patients with malignant solid tumors confirmed by histopathology or cytology and having at least one measurable lesion.
- Fresh biopsy specimens can be provided for vaccine preparation.
- Patients with malignant solid tumors who develop secondary drug resistance after receiving PD-1/PD-L1 drug therapy, including but not limited to gastric cancer, esophageal cancer, and other gastrointestinal tumors of MSI-H
Who cannot join
- It is known that it is allergic to any tumor vaccine and Sintilimab preparations; Or have experienced severe allergic reactions to other monoclonal antibodies in the past;
- The predicted number of new antigens is less than 10;
- Those who are pregnant or breastfeeding;
- Those with an expected survival period of less than 3 months;
About this study
Official title: Clinical Study on the Treatment of Advanced Malignant Solid Tumors With the Combination of mRNA
This study is an open, single arm, dose increasing study to evaluate the safety and efficacy of the combination of mRNA personalized tumor vaccine encoding neoantigen (hereinafter referred to as tumor vaccine) and Sintilimab injection (hereinafter referred to as Sintilimab) in the treatment of advanced malignant solid tumors.
- Conditions
- Advanced Malignant Solid Tumors
- Being tested
- Neoantigen mRNA Personalised Cancer vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoantigen mRNA Personalised Cancer vaccineBiological
Drug: Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab Injection Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Neoantigen mRNA Personalised Cancer in combination with Stintilimab Injection. Participants will receive a total of 9 cycles of PCV every 21 days Receives: Biological: Neoantigen mRNA Personalised Cancer vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
Measured: Time Frame: from enrolling to patients disease progression，assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start20 Jul 2023 (estimated)
- Primary completion12 Dec 2025 (estimated)
- Study completion20 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- PD-1/PD-L1 drug therapy benefits patients with secondary drug-resistant malignant solid tumors, including but not limited to gastric cancer, esophageal cancer, and other gastrointestinal tumors of MSI-H.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stemirna Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949775
- Sponsor's protocol ID
- 2020-06-mRNA-COM
- Status last verified
- Jun 2023
- First submitted
- 28 Jun 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Treatment of Advanced Malignant Solid Tumors With the Combination of mRNA
- ClinicalTrials.gov ID
- NCT05949775
- Acronym / sponsor ID
- 2020-06-mRNA-COM
- Conditions
- Advanced Malignant Solid Tumors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stemirna TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute
- Study start
- 20 Jul 2023 (estimated)
- Primary completion
- 12 Dec 2025 (estimated)
- Study completion
- 20 Mar 2026 (estimated)
- First posted
- 18 Jul 2023 (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.
This study is an open, single arm, dose increasing study to evaluate the safety and efficacy of the combination of mRNA personalized tumor vaccine encoding neoantigen (hereinafter referred to as tumor vaccine) and Sintilimab injection (hereinafter referred to as Sintilimab) in the treatment of advanced malignant solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PD-1/PD-L1 drug therapy benefits patients with secondary drug-resistant malignant solid tumors, including but not limited to gastric cancer, esophageal cancer, and other gastrointestinal tumors of MSI-H.
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Biological: Neoantigen mRNA Personalised Cancer vaccineNeoantigen mRNA Personalised Cancer in combination with Stintilimab Injection. Participants will receive a total of 9 cycles of PCV every 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are ≥18 years old, without limitation of sex at time of consent.
- Patients with malignant solid tumors confirmed by histopathology or cytology and having at least one measurable lesion.
- Fresh biopsy specimens can be provided for vaccine preparation.
- Patients with malignant solid tumors who develop secondary drug resistance after receiving PD-1/PD-L1 drug therapy, including but not limited to gastric cancer, esophageal cancer, and other gastrointestinal tumors of MSI-H
Key exclusion criteria (4 listed)
- It is known that it is allergic to any tumor vaccine and Sintilimab preparations; Or have experienced severe allergic reactions to other monoclonal antibodies in the past;
- The predicted number of new antigens is less than 10;
- Those who are pregnant or breastfeeding;
- Those with an expected survival period of less than 3 months;
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 |
|---|---|---|
| Neoantigen mRNA Personalised Cancer vaccineDrug: Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab Injection Subcutaneous Injection | Biological | single arm |
Primary outcome
progression-free survival (PFS)
Time frame: Time Frame: from enrolling to patients disease progression，assessed up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Neoantigen mRNA Personalised Cancer vaccine in people with Advanced Malignant Solid Tumors, run by Stemirna Therapeutics.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (PFS) (time frame: Time Frame: from enrolling to patients disease progression，assessed up to 24 months). 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 18 Jul 2023.