A Study of the RNA Tumor Vaccine Targeting MICA/B in Patients With Advanced Solid Tumors (NCT06610227) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
A Study of the RNA Tumor Vaccine Targeting MICA/B in Patients With Advanced Solid Tumors
China18 participantsStarted 2024-11-08
Plain-language summary
This is an open-label, single-arm study to evaluate the safety and efficacy of multiple doses of SapRNAâ„¢-MICA/B Tumor Vaccine in patients with advanced solid tumors. Eligible patients will receive the monotherapy with SapRNAâ„¢-MICA/B Tumor Vaccine, which will be administered by intramuscular injection on Day 1, Day 14, and Day 28 respectively. Follow-up visits will be performed as scheduled after the end of treatment.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years, male or female;
* Expected survival ≥12 weeks;
* Patients with advanced solid tumors as confirmed by cytology or histology who fail standard of care (progressed after treatment or intolerant to the treatment) and have no effective treatment available, or have no standard of care available, or unable to receive standard of care due to limitation of objective conditions;
* Patients with at least 1 measurable lesion as per RECIST v1.1;
* Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
* Patients with adequate organ and bone marrow function. Definitions are as follows:
* Hematology: Absolute neutrophil count (ANC) ≥1.5×109/L; platelet count (PLT) ≥100×109/L; haemoglobin (HGB) ≥9.0 g/dL. No treatment with granulocyte colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), red blood cell transfusion, and platelet transfusion within 14 days prior to the assessment.
* Liver function:
* Patients with liver metastases: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5×upper limit of normal (ULN), and total bilirubin ≤1.5×ULN (exception: for patients with Gilbert's syndrome, total bilirubin ≤3.0×ULN is acceptable if direct bilirubin ≤35%).
* Patients without liver metastases: AST and ALT ≤2.5×ULN, and total bilirubin ≤1.5×ULN (exception: for patients with Gilbert's syndrome, total bilirubin ≤3.0×ULN is acceptable if direct bilirubin ≤35%).
* K…
What they're measuring
1
adverse events
Timeframe: From enrollment to the end of treatment at 30 days