This is an open-label, single-arm study to evaluate the safety and efficacy of multiple doses of SapRNA™-MICA/B Tumor Vaccine in patients with advanced solid tumors. Eligible patients will receive the monotherapy with SapRNA™-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.
This is an open-label, single-arm study to evaluate the safety and efficacy of multiple doses of SapRNA™-MICA/B Tumor Vaccine in patients with advanced solid tumors. The primary study objective is to evaluate the safety, tolerability, and efficacy of a single dose of SapRNA™-MICA/B Tumor Vaccine in patients. Eligible patients will receive the monotherapy with SapRNA™-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. The patients will be followed up until disease progression, occurrence of intolerable toxicity, initiation of a new antitumor therapy, withdrawal of informed consent, loss to follow-up, death, or any other protocol-specified conditions for which the treatment should be discontinued, whichever earlier. Throughout the study, the safety after multiple doses will be evaluated as per the schedule of activities. Endpoints like objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS) will be evaluated as per the RECIST v1.1 by the investigator. After discontinuation or completion of the study treatment, the end of treatment visit, safety follow-up visit (6 months after end of the last dose), and survival follow-up visit will be performed for the patients. The dose escalation and tolerability study is proposed to be conducted in the two dose groups of 5×106 and 5×107 active nanoparticles. The patients will receive the treatment at a fixed dose in the study. The dose escalation will be performed with reference to the 3+3 design during the dose-limiting toxicity (DLT) observation period, with 3 patients enrolled first and observed for DLTs from Day 1 to Day 35. If none of the first 3 patients experience DLTs, the study will proceed to the next higher dose level; if 2/3 patients experience DLTs, the study will be stopped; if 1/3 patients experiences DLTs, additional 3 patients will be enrolled: if 1/6 patients experiences DLTs, the study will proceed to the next higher dose level; otherwise, the study will be stopped.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
patients will receive the monotherapy with SapRNA™-MICA/B Tumor Vaccine, which will be administered by intramuscular injection on Day 1, Day 14, and Day 28 respectively
National Cancer Center
Beijing, Beijing Municipality, China
adverse events
Frequency, number, incidence, and severity of the adverse events and adverse reactions
Time frame: From enrollment to the end of treatment at 30 days
Objective response rate (ORR)
Objective response rate will be estimated by CT or MRI depending on the cancer type and location, according to RESIST V1.1.
Time frame: Every 6 weeks from the first dose of treatment until the date of first documented progression, the start of other treatment, or date of death from any cause, whichever came first, up to 2 years
Immunogenicity
Change in vaccine-specific antibody (IgG) after treatment will be measured.
Time frame: 1 hour before injection at Day 1, Day 14, and Day 28, and then Week 7 and Week 16
Target protein expression
Levels of serum MICA/B stress proteins will be measured by ELISA.
Time frame: 1 hour before injection at Day 1, and then Week 7 and Week 16
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