Solid TumorNCT05359354
Safety and Efficacy of Personalized Neoantigen Vaccine in Advanced Solid Tumors
A study testing Personalized neoantigen tumor vaccine in people with Solid Tumor, run by YueJuan Cheng at 1 site in China.
Trial summary
This trial is an investigator-initiated, single-center, open-label, single-arm exploratory study of mRNA personalized neoantigen tumor vaccine in the treatment of advanced solid tumors, including two phases: dose escalation and dose expansion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Personalized neoantigen tumor vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to Dec 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signed and provided formal informed consent;
- Male and female patients aged 18-75 years (inclusive);
- Expected survival ≥ 3 months;
- Subject with advanced solid tumor proved by histopathology or cytology and who have failed to respond to standard treatment;
- At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors RECIST v1.1 (see Appendix 4, Response Evaluation Criteria in Solid Tumors) (i.e., mass ≥ 10 mm in diameter and malignant lymph node ≥ 15 mm in short diameter on enhanced spiral CT ≤ 5 mm);
- ECOG performance status score of 0 ~ 2;
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- Treatment with other antineoplastic agents (e.g., chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy) for more than 5 half-lives of this agent or more than 4 weeks from baseline (whichever is shorter) during the baseline period ;
- The organ function level must meet the following requirements (no blood transfusion or blood products, no hematopoietic stimulating factors, no albumin or blood products): absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet count (PLT) ≥ 75 × 10^9/L, hemoglobin (Hb) ≥ 90 g/L; serum total bilirubin (TBIL) ≤ 1.5 ×ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN (if there is liver metastasis, total bilirubin ≤ 3 ×ULN, AST, ALT ≤ 5 ×ULN are allowed); Note: These laboratory tests may only be repeated once if the investigator deems it necessary (the reason for retest must be documented). If the criteria are met after retest, the laboratory parameter can be considered qualified.
- Premenopausal women of childbearing potential must have a negative pregnancy test within 7 days prior to initiation of treatment and be non-lactating; women of non-childbearing potential are not required to have a pregnancy test and contraception unless participants are 50 years of age or older, have not used hormonal therapy and have been amenorrheic for at least 12 months, or have been surgically sterilized. All subjects (male or female) should use adequate barrier contraception throughout treatment and for 3 months after the end of treatment.
Who cannot join
- Subject who need to receive systemic application of anti-allergic drugs for a long time, or have a history of life-threatening allergic reactions to any vaccine or drug;
- Symptomatic or rapidly progressive central nervous system metastases. Patients with extensive lung metastases resulting in dyspnea; patients with tumors close to or invading major blood vessels or nerves;
- New cerebrovascular accident (including ischemic stroke, hemorrhagic stroke, and transient ischemic attack) within 6 months before screening;
- Subject with acute myocardial infarction within 6 months before screening, or uncontrolled angina, uncontrolled arrhythmia, severe heart failure (see Appendix 3, New York Heart Association Heart Failure Classification Criteria NYHA Class ≥ III) and other cardiovascular diseases;
- Subject who have received treatment with immunomodulatory drugs 4 times before the first vaccination day (D1), including but not limited to: IL-2, CTLA-4 inhibitors, CD40 agonists, CD137 agonists, IFN-α (except for high-risk surgical subjects who use IFN-α as adjuvant therapy, if IFN-α treatment is stopped 4 times before this trial); Subject with a history of renal insufficiency, serum creatinine level greater than 1.5 times the upper limit of normal;
- Subject who received blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) before baseline;
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- Subject with skin diseases (e.g., psoriasis) at baseline that may prevent the intradermal injection of vaccine into the target area;
- Subject still suffer from adverse reactions (except alopecia and platinum-induced neurotoxicity ≤ grade 2) that have not been restored to CTCAE version 5.0 grade ≤ 1 after previous anti-tumor treatment during the screening period;
- Concomitant use of steroid hormone drugs (tumor or non-tumor related diseases) is required; however, topical application (not applied to the vaccination site) or inhaled steroid drugs are required;
- Subject has an active infection or uncontrollable infection (except for simple urinary tract infection or upper respiratory tract infection) requiring systemic treatment; subjects with positive human immunodeficiency virus antibody, hepatitis B surface antigen and/or hepatitis B core antibody and positive hepatitis B virus deoxyribonucleic acid > 10^3 IU/mL, hepatitis C virus antibody, Treponema pallidum-specific antibody in virological monitoring during the screening period;
- Hypertension poorly controlled on treatment (defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
- Subject with other malignant tumors within 5 years before the screening period, except for cervical carcinoma in situ, breast carcinoma in situ and cutaneous basal cell carcinoma that have received appropriate treatment and met the recovery criteria;
- Subject with a history of autoimmune diseases [such as, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (hypothyroidism without clinical symptoms or hypothyroidism caused by chemoradiotherapy can be included), subjects with vitiligo or recovered asthma can be included without any intervention, and subjects with asthma requiring bronchodilators for medical intervention cannot be included];
- Subject with active ulcer or gastrointestinal bleeding during the screening period;
- Subject who has previously received similar therapeutic tumor vaccines;
- Subject with congenital or acquired immunodeficiency;
- Subjects with congenital or acquired immunodeficiency;
- Subjects who are still involved in other clinical trials and have not been enrolled during the screening period;
- Known active pulmonary tuberculosis (TB). Subjects suspected of active TB should be examined for chest imaging and excluded from clinical symptoms and signs;
- Major surgical procedure (defined by the investigator as open biopsy, significant trauma, etc) within 4 weeks prior to the first dose of study drug. Note: Replacement of intravenous infusion dropper is acceptable. Has a major surgical plan within 30 days of the first dose, at the discretion of the investigator, or has not fully recovered from prior surgery. Local surgery (e.g., placement of a systemic port, core needle biopsy, and prostate biopsy) is permitted provided it was completed at least 24 hours prior to the first dose of study treatment;
- Subjects who, in the opinion of the investigator, have an underlying health condition, mental condition or social situation and are unable or unwilling to comply with the study protocol;
- Other severe, acute or chronic medical condition or psychiatric condition or laboratory abnormality that, in the judgment of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
YueJuan Cheng, 861069158315, cnchengyuejuan@yahoo.com
About this study
Official title: A Dose-Escalation and Dose-Expansion Study Evaluating the Safety and Efficacy of Personalized Neoantigen Vaccine in Advanced Solid Tumors
This trial is an investigator-initiated, single-center, open-label, single-arm exploratory study of mRNA personalized neoantigen tumor vaccine in the treatment of advanced solid tumors, including two phases: dose escalation and dose expansion. The main objective is to evaluate the safety and tolerability of personalized neoantigen tumor vaccine in subjects with advanced solid tumors, and secondary objective is to preliminarily evaluate the efficacy of personalized neoantigen tumor vaccine in subjects with advanced solid tumors. According to the characteristics of safety and efficacy data in the dose escalation phase, the dose expansion is performed at the intended clinical dose based on the investigator's judgment, and the treatment will be performed in combination with PD-1 to further evaluate the efficacy and safety profile of personalized neoantigen tumor vaccine at a specific dose.
Both the dose escalation phase and dose expansion phase include a screening period (Week -4 ~ Week -2), a baseline period (Week -1 ~ Day -1), a treatment period (Day 1 ~ Week 8 or 16), and a follow-up period. Subjects who signed and provided the formal informed consent entered the screening period. The treatment period included the initial treatment period (Day 1 ~ Week 8) and the enhanced treatment period (Week 12 ~ Week 16). The investigator determine if the subject is suitable to enter the enhanced treatment period based on the comprehensive judgment of the subject's efficacy, safety, compliance and other factors.
Read more
Dose escalation phase is the traditional 3 + 3 design,, 12-18 subjects are expected to be enrolled at 100 μg, 200 μg and 400 μg (3-6 subjects in each group). The low dose group will be enrolled first.
The investigator will choose the optimal clinical dose for dose expansion, which can be one dose group or multiple dose groups. PD-1 will be administered in parallel to further confirm the efficacy and safety of neoantigen tumor vaccine. About 18 subjects will be enrolled. The usage and dosage of PD-1 should aligned with the package insert.
- Conditions
- Solid Tumor
- Being tested
- Personalized neoantigen tumor vaccine
- Keywords
- Vaccine, Neoantigen, Solid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized neoantigen tumor vaccineBiological
Also called PGV002 mRNA Vaccine
Biological: neoantigen tumor vaccine with or without PD-1 In dose escalation phase, subjects will receive neoantigen tumor vaccine only. In dose expansion phase, subjects will receive neoantigen tumor vaccine combination with PD-1
| Study group | Role | What they receive |
|---|---|---|
| Personalized neoantigen vaccine or neoantigen tumor vaccine + PD-1 | Experimental | In dose escalation phase, subject will only receive personalized neoantigen tumor vaccine. In dose expansion phase, subject will receive personalized neoantigen tumor vaccine combination with PD-1. Receives: Biological: Personalized neoantigen tumor vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) or recommended clinical dose
Measured: Up to 16 weeks
Dose-limiting toxicity(DLT)
Measured: Up to 16 weeks
Incidence and degree of Adverse Events and Serious Adverse Events [Safety]
Measured: Up to 100 weeks
Secondary outcomes (2)
Reaction of antigen-specific T cells in peripheral blood
Measured: Up to 16 weeks
Efficacy indicators: Objective response rate (ORR)
Objective response rate (ORR: complete response [CR] + partial response [PR]), duration of response (DoR), best response rate (BOR), disease control rate (DCR: CR + PR + stable disease [SD]), progression-free survival (PFS), and overall survival (OS) based on RECIST 1.1.
Measured: Up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 Sep 2022
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The traditional 3+3 design will be used in dose escalation.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YueJuan Cheng
- Sponsor type
- University, hospital or other
- Collaborators
- NeoCura
- Responsible party
- Sponsor-investigator, YueJuan Cheng, Peking Union Medical College Hospital
- Investigators
- Chunmei Bai, Dr., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359354
- Sponsor's protocol ID
- XKY- 1007
- Status last verified
- May 2023
- First submitted
- 25 Apr 2022
- Last updated
- 16 May 2023
- 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 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Escalation and Dose-Expansion Study Evaluating the Safety and Efficacy of Personalized Neoantigen Vaccine in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05359354
- Acronym / sponsor ID
- XKY- 1007
- Conditions
- Solid Tumor
- Keywords
- Vaccine, Neoantigen, Solid Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- YueJuan ChengUniversity, hospital or other
- Collaborators
- NeoCura
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 May 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 trial is an investigator-initiated, single-center, open-label, single-arm exploratory study of mRNA personalized neoantigen tumor vaccine in the treatment of advanced solid tumors, including two phases: dose escalation and dose expansion. The main objective is to evaluate the safety and tolerability of personalized neoantigen tumor vaccine in subjects with advanced solid tumors, and secondary objective is to preliminarily evaluate the efficacy of personalized neoantigen tumor vaccine in subjects with advanced solid tumors. According to the characteristics of safety and efficacy data in the dose escalation phase, the dose expansion is performed at the intended clinical dose based on the investigator's judgment, and the treatment will be performed in combination with PD-1 to further evaluate the efficacy and safety profile of personalized neoantigen tumor vaccine at a specific dose.
Both the dose escalation phase and dose expansion phase include a screening period (Week -4 ~ Week -2), a baseline period (Week -1 ~ Day -1), a treatment period (Day 1 ~ Week 8 or 16), and a follow-up period. Subjects who signed and provided the formal informed consent entered the screening period. The treatment period included the initial treatment period (Day 1 ~ Week 8) and the enhanced treatment period (Week 12 ~ Week 16). The investigator determine if the subject is suitable to enter the enhanced treatment period based on the comprehensive judgment of the subject's efficacy, safety, compliance and other factors.
Dose escalation phase is the traditional 3 + 3 design,, 12-18 subjects are expected to be enrolled at 100 μg, 200 μg and 400 μg (3-6 subjects in each group). The low dose group will be enrolled first.
The investigator will choose the optimal clinical dose for dose expansion, which can be one dose group or multiple dose groups. PD-1 will be administered in parallel to further confirm the efficacy and safety of neoantigen tumor vaccine. About 18 subjects will be enrolled. The usage and dosage of PD-1 should aligned with the package insert.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The traditional 3+3 design will be used in dose escalation.
| Arm | Type | Receives |
|---|---|---|
| Personalized neoantigen vaccine or neoantigen tumor vaccine + PD-1 | Experimental | Biological: Personalized neoantigen tumor vaccineIn dose escalation phase, subject will only receive personalized neoantigen tumor vaccine. In dose expansion phase, subject will receive personalized neoantigen tumor vaccine combination with PD-1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily signed and provided formal informed consent;
- Male and female patients aged 18-75 years (inclusive);
- Expected survival ≥ 3 months;
- Subject with advanced solid tumor proved by histopathology or cytology and who have failed to respond to standard treatment;
- At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors RECIST v1.1 (see Appendix 4, Response Evaluation Criteria in Solid Tumors) (i.e., mass ≥ 10 mm in diameter and malignant lymph node ≥ 15 mm in short diameter on enhanced spiral CT ≤ 5 mm);
Key exclusion criteria (22 listed)
- Subject who need to receive systemic application of anti-allergic drugs for a long time, or have a history of life-threatening allergic reactions to any vaccine or drug;
- Symptomatic or rapidly progressive central nervous system metastases. Patients with extensive lung metastases resulting in dyspnea; patients with tumors close to or invading major blood vessels or nerves;
- New cerebrovascular accident (including ischemic stroke, hemorrhagic stroke, and transient ischemic attack) within 6 months before screening;
- Subject with acute myocardial infarction within 6 months before screening, or uncontrolled angina, uncontrolled arrhythmia, severe heart failure (see Appendix 3, New York Heart Association Heart Failure Classification Criteria NYHA Class ≥ III) and other cardiovascular diseases;
- Subject who have received treatment with immunomodulatory drugs 4 times before the first vaccination day (D1), including but not limited to: IL-2, CTLA-4 inhibitors, CD40 agonists, CD137 agonists, IFN-α (except for high-risk surgical subjects who use IFN-α as adjuvant therapy, if IFN-α treatment is stopped 4 times before this trial); Subject with a history of renal insufficiency, serum creatinine level greater than 1.5 times the upper limit of normal;
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 |
|---|---|---|
| Personalized neoantigen tumor vaccineAlso: PGV002 mRNA VaccineBiological: neoantigen tumor vaccine with or without PD-1 In dose escalation phase, subjects will receive neoantigen tumor vaccine only. In dose expansion phase, subjects will receive neoantigen tumor vaccine combination with PD-1 | Biological | Personalized neoantigen vaccine or neoantigen tumor vaccine + PD-1 |
Primary outcome
Maximum tolerated dose (MTD) or recommended clinical dose
Time frame: Up to 16 weeks
Dose-limiting toxicity(DLT)
Time frame: Up to 16 weeks
Incidence and degree of Adverse Events and Serious Adverse Events [Safety]
Time frame: Up to 100 weeks
2 secondary outcomes
Reaction of antigen-specific T cells in peripheral blood
Time frame: Up to 16 weeks
Efficacy indicators: Objective response rate (ORR)
Time frame: Up to 100 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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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.
Chunmei Bai, Dr. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized neoantigen tumor vaccine in people with Solid Tumor, run by YueJuan Cheng 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 22 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 16 May 2023. 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.
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 Chunmei Bai, Dr. (86-10-69158773, jessiesz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) or recommended clinical dose (time frame: Up to 16 weeks). 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 16 May 2023.