NCT06610227

A Study of the RNA Tumor Vaccine Targeting MICA/B in Patients With Advanced Solid Tumors

A Clinical Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, and Immunogenicity of the Novel RNA Tumor Vaccine Targeting MICA/B Stress Proteins in Patients With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: NING LI · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	SapRNA™-MICA/B Tumor Vaccine	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

Timeline

• Start date: 2024-11-08
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2024-09-24
• Last updated: 2025-07-16

Locations

1 site across 1 country: China