Advanced Solid TumorPhase 1NCT05202561
A Study of RNA Tumor Vaccine in Patients With Advanced Solid Tumors
A Phase 1 study testing RNA tumor vaccine and RNA tumor vaccine+Navuliumab in people with Advanced Solid Tumor, run by The First Affiliated Hospital of Bengbu Medical University at 1 site in China.
Trial summary
This is a single-arm, open-label, clinical pharmacology study to evaluate the safety of RNA tumor vaccine injection alone/in combination with PD-1 inhibitor in the treatment of advanced solid tumors with KRAS mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- RNA tumor vaccine and RNA tumor vaccine+Navuliumab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2022to 19 Jan 2024
- Phase
- Phase 1
- 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
- The patient is at least 18 years old with no gender limitation;
- Patients with advanced malignant solid tumors confirmed by histopathology or cytology and failed to receive standard treatment or without standard treatment;
- Identification of at least one KRAS mutation: G12C, G12D or G12V;
- The subtype was identified as HLA-A11:01 or C08:02;
- Have at least one measurable lesion according to RECIST V1.1;
- ECOG PS score was 0-2 in the Eastern Oncology Group;
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- Full organ and bone marrow function, as defined below:
- Sign written informed consent and be able to comply with the visits and related procedures specified in the program;
- Eligible fertile patients (male and female) must agree to use a reliable contraceptive method (hormonal or barrier methods or abstinence) during the study period;
Who cannot join
- A history of severe allergy to biological products;
- Those in pregnancy or lactation;
- The expected survival time is less than 3 months;
- Those who have undergone major surgery within 4 weeks prior to signing the informed consent, or who plan to undergo major surgery during the study period;
- Received chemotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor drugs within 2 weeks before the first administration;
- Participating in other clinical studies;
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- Patients with central nervous system metastasis or a history of central nervous system metastasis;
- Adverse effects of previous antitumor therapy have not recovered to NCI CTCAE V5.0 rating ≤1 (except hair loss);
- Serious cardiovascular and cerebrovascular diseases, hypertension that is still poorly controlled after standard treatment (systolic blood pressure > 150mmHg, diastolic blood pressure > 90mmHg);
- Patients with active ulcers and gastrointestinal bleeding;
- Patients with uncontrollable pleural effusion, abdominal effusion and pericardial effusion;
- Active infection requiring treatment;
- HIV, HCV, syphilis, CMV, EBV infected patients; Patients with active HBV replication;
- A history of interstitial lung disease;
- The patient has an autoimmune disease or is in an immunosuppressed state; Current systemic steroid use (except recent or current inhaled steroid use);
- Other conditions that the investigator assessed as ineligible for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital Bengbu Medical College
Bengbu, Anhui, 233030
Zhou huan, MD, 13665527160, zhouhuanbest@163.com
About this study
Official title: A Single-Arm, Open-Label, Exploratory Study to Evaluate the Safety of RNA Tumor Vaccine Injection Alone/in Combination With PD-1 Inhibitor in the Treatment of Advanced Solid Tumors With KRAS Mutation
This is a single-arm, open-label, clinical pharmacology study to evaluate the safety of RNA tumor vaccine injection alone/in combination with PD-1 inhibitor in the treatment of advanced solid tumors with KRAS mutation.
The purpose of this study is to evaluate the safety and tolerability, antitumor activity, The immunoreactivity, pharmacokinetics and of RNA tumor vaccine.
Read the detailed description
This is an investigator initiated , sinle-arm, open-label clinical pharmacology to evaluate the safety and efficacy of RNA vaccine injection alone/in combination with PD-1 inhibitor in patients with advanced solid tumors with KRAS mutation (G12C, G12D, or G12V) and HLA type HLA-A11:01 or HLA C08:02. 10 subjects were enrolled. Monotherapy and combination therapy are included. Some eligible subjects will receive single drug therapy with RNA tumor vaccine injection, and some will receive combined treatment with PD-1. Among them:
Arm A:RNA tumor vaccine The single-agent study evaluated the safety, efficacy and pharmacokinetic characteristics of a fixed-dose (600ng) KRAS-targeted RNA vaccine injection as a single agent in humans. Eligible subjects will receive a single dose of RNA vaccine injection on day 1, day 4, day 7, and day 14, each dose of 600ng.
Arm B: RNA tumor vaccine+Navuliumab Subjects will receive maintenance therapy with a PD-1 inhibitor in addition to monotherapy with the RNA tumor vaccine injection. Subjects received a single dose of RNA vaccine injection on day 1, day 4, day 7, and day 14, with each dose of 600 ng. Inhibitors, accept the Navuliumab on day 14, the recommended dose is 3 mg/kg, intravenous injection every 2 weeks.
- Conditions
- Advanced Solid Tumor
- Being tested
- RNA tumor vaccine, RNA tumor vaccine+Navuliumab
- Keywords
- KRAS mutation, RNA tumor vaccine, injection, PD-1, immunotherapy, Advanced Solid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNA tumor vaccineBiological
Subjects will receive single dose of RNA tumor vaccine injection on day 1, day 4, day 7, and day 14, each dose of 600 ng.
RNA tumor vaccine+NavuliumabBiological
RNA tumor vaccine+Navuliumab Subjects will receive maintenance therapy with a PD-1 inhibitor in addition to monotherapy with the RNA tumor vaccine injection. Subjects received a single dose of RNA vaccine injection on day 1, day 4, day 7, and day 14, with each dose of 600 ng. Inhibitors, accept the Navuliumab on day 14, the recommended dose is 3 mg/kg, intravenous injection every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Drug: RNA tumor vaccine Administration: intramuscular injection Dose: 600 ng/ time Dosing cycle: Day 1, day 4, day 7, and day 14. Receives: Biological: RNA tumor vaccine |
| Arm B | Experimental | Drug: RNA tumor vaccine+Navuliumab Administration: intravenous injection Dose: 3 mg/kg Timing of administration: Administration was initiated 14 days after the first intramuscular injection of the RNA tumor vaccine.
Duration of administration: once every 2 weeks. Receives: Biological: RNA tumor vaccine+Navuliumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Graded according to the NCI CTCAE version 5.0.
Measured: Up to 6 months
Secondary outcomes (2)
To evaluate the antitumor activity
To assess per RECIST and iRECIST
Measured: Up to 2 years
The changes of the immunoreactivity during treatment.
Peripheral blood T lymphocyte subtype
Measured: Up to 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start10 Mar 2022
- Primary completion19 Jan 2023 (estimated)
- Study completion19 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Zishu, The First Affiliated Hospital of Bengbu Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202561
- Sponsor's protocol ID
- LWY21084CBY
- Status last verified
- Mar 2022
- First submitted
- 19 Jan 2022
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Exploratory Study to Evaluate the Safety of RNA Tumor Vaccine Injection Alone/in Combination With PD-1 Inhibitor in the Treatment of Advanced Solid Tumors With KRAS Mutation
- ClinicalTrials.gov ID
- NCT05202561
- Acronym / sponsor ID
- LWY21084CBY
- Conditions
- Advanced Solid Tumor
- Keywords
- KRAS mutation, RNA tumor vaccine, injection, PD-1, immunotherapy, Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical UniversityUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 19 Jan 2023 (estimated)
- Study completion
- 19 Jan 2024 (estimated)
- First posted
- 21 Jan 2022 (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 is a single-arm, open-label, clinical pharmacology study to evaluate the safety of RNA tumor vaccine injection alone/in combination with PD-1 inhibitor in the treatment of advanced solid tumors with KRAS mutation.
The purpose of this study is to evaluate the safety and tolerability, antitumor activity, The immunoreactivity, pharmacokinetics and of RNA tumor vaccine.
Detailed description
This is an investigator initiated , sinle-arm, open-label clinical pharmacology to evaluate the safety and efficacy of RNA vaccine injection alone/in combination with PD-1 inhibitor in patients with advanced solid tumors with KRAS mutation (G12C, G12D, or G12V) and HLA type HLA-A11:01 or HLA C08:02. 10 subjects were enrolled. Monotherapy and combination therapy are included. Some eligible subjects will receive single drug therapy with RNA tumor vaccine injection, and some will receive combined treatment with PD-1. Among them:
Arm A:RNA tumor vaccine The single-agent study evaluated the safety, efficacy and pharmacokinetic characteristics of a fixed-dose (600ng) KRAS-targeted RNA vaccine injection as a single agent in humans. Eligible subjects will receive a single dose of RNA vaccine injection on day 1, day 4, day 7, and day 14, each dose of 600ng.
Arm B: RNA tumor vaccine+Navuliumab Subjects will receive maintenance therapy with a PD-1 inhibitor in addition to monotherapy with the RNA tumor vaccine injection. Subjects received a single dose of RNA vaccine injection on day 1, day 4, day 7, and day 14, with each dose of 600 ng. Inhibitors, accept the Navuliumab on day 14, the recommended dose is 3 mg/kg, intravenous injection every 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Biological: RNA tumor vaccineDrug: RNA tumor vaccine Administration: intramuscular injection Dose: 600 ng/ time Dosing cycle: Day 1, day 4, day 7, and day 14. |
| Arm B | Experimental | Biological: RNA tumor vaccine+NavuliumabDrug: RNA tumor vaccine+Navuliumab Administration: intravenous injection Dose: 3 mg/kg Timing of administration: Administration was initiated 14 days after the first intramuscular injection of the RNA tumor vaccine. Duration of administration: once every 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient is at least 18 years old with no gender limitation;
- Patients with advanced malignant solid tumors confirmed by histopathology or cytology and failed to receive standard treatment or without standard treatment;
- Identification of at least one KRAS mutation: G12C, G12D or G12V;
- The subtype was identified as HLA-A11:01 or C08:02;
- Have at least one measurable lesion according to RECIST V1.1;
Key exclusion criteria (16 listed)
- A history of severe allergy to biological products;
- Those in pregnancy or lactation;
- The expected survival time is less than 3 months;
- Those who have undergone major surgery within 4 weeks prior to signing the informed consent, or who plan to undergo major surgery during the study period;
- Received chemotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor drugs within 2 weeks before the first administration;
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 |
|---|---|---|
| RNA tumor vaccineSubjects will receive single dose of RNA tumor vaccine injection on day 1, day 4, day 7, and day 14, each dose of 600 ng. | Biological | Arm A |
| RNA tumor vaccine+NavuliumabRNA tumor vaccine+Navuliumab Subjects will receive maintenance therapy with a PD-1 inhibitor in addition to monotherapy with the RNA tumor vaccine injection. Subjects received a single dose of RNA vaccine injection on day 1, day 4, day 7, and day 14, with each dose of 600 ng. Inhibitors, accept the Navuliumab on day 14, the recommended dose is 3 mg/kg, intravenous injection every 2 weeks. | Biological | Arm B |
Primary outcome
Incidence of adverse events
Time frame: Up to 6 months
Graded according to the NCI CTCAE version 5.0.
2 secondary outcomes
To evaluate the antitumor activity
Time frame: Up to 2 years
The changes of the immunoreactivity during treatment.
Time frame: Up to 28 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RNA tumor vaccine and RNA tumor vaccine+Navuliumab in people with Advanced Solid Tumor, run by The First Affiliated Hospital of Bengbu Medical University at 1 site 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 9 inclusion and 16 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 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhou huan, MD (13665527160, zhouhuanbest@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 6 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 23 Mar 2022.