Status:
UNKNOWN
A Study of RNA Tumor Vaccine in Patients With Advanced Solid Tumors
Lead Sponsor:
The First Affiliated Hospital of Bengbu Medical University
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 w...
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 a...
Eligibility Criteria
Inclusion
- 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;
- 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;
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
March 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 19 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05202561
Start Date
March 10 2022
End Date
January 19 2024
Last Update
March 23 2022
Active Locations (1)
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1
First Affiliated Hospital Bengbu Medical College
Bengbu, Anhui, China, 233030