NCT06713148

Study on the Safety and Efficacy of Intratumoral Administration of IDOV-SAFETM in the Treatment of Advanced Solid Tumors

A Phase I Clinical Study on the Safety and Efficacy of Intratumoral Administration of IDOV-SAFETM in the Treatment of Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, dose escalation, phase I study to evaluate safety tolerability, MTD, pharmacokinetic profile, immunogenicity, and pharmacodynamic profile of intratumoral Administration of IDOV-SAFETM in patients with advanced solid tumors.

Detailed description

The therapeutic dose for mice was 1x10\^8 PFU, and the maximum starting dose for humans was 2.67x10\^9 PFU based on the Guidelines for Estimating the Maximum Recommended Starting Dose for the First Clinical Trial of Healthy Adult Volunteers. Dose escalation phase: At this stage, the investigators plan to enroll about 13-25 patients with advanced malignant solid tumors confirmed by histology or cytology after failure of standard treatment or without standard treatment in China for intratumoral injection of IDOV-SAFETM. This phase consisted of five dose groups: 1x10\^8 PFU, 3x10\^8 PFU, 7x10\^8 PFU, 1x10\^9 PFU and 3x10\^9 PFU. The first dose group included 1 subject, and the other dose groups were increased by "3+3", with 3-6 subjects in each group. Each patient received intratumoral injection on the first day, 14 days as a course of treatment. The follow-up investigator decided whether to continue the second (D14) and third (D28) course of administration according to the comprehensive assessment of the subjects' conditions; All subjects in each dose group may be incremented to the next dose group after completing a safety assessment 21 days after the first dose. The dose escalation or setting may be adjusted as determined by the Safety Committee (SMC). Dose expansion phase: According to the results of the phase I trial, one dose was selected for dose expansion, and the selected dose level was extended to 5\~18 patients. Each patient received intratumoral injection on the first day, and 14 days was a course of treatment. The subsequent investigators decided whether to continue the administration of the second (D14) and third (D28) courses according to the comprehensive evaluation of the subjects' conditions. Each patient was treated for at least one course of treatment (14 days). Based on the preliminary clinical trial data, the number of injections and the interval time of administration can be adjusted during the dose expansion phase after the decision of the Safety Committee (SMC). Duration of administration: In both phases, safety and efficacy were evaluated 42 days after initial dosing. If CT evaluation suspects false progression, puncture and pathology examination are required. After SMC's decision, it is determined that the benefits of continued treatment outweigh the risks of the subject, and if the subject wishes to continue treatment, the subject may continue to receive the experimental drug. The specific course of treatment will be determined by the SMC based on preliminary clinical trial data. The safety and efficacy of the investigational drug will be evaluated periodically during continued dosing, and the risk and benefit of continuing treatment will be determined by the SMC. If benefit \> risk is no longer satisfied, the long-term safety and survival follow-up period is entered. Long-term safety and survival follow-up: Adverse events occurring throughout the study from the first dosing of each subject in both phases will be collected, and long-term safety and survival follow-up will continue up to 2 years after the last dosing (site visits every 8 weeks from the DLT observation period until patients meet end-of-treatment criteria or the end of survival follow-up date, whichever arrives first).

Conditions

• Advanced Malignant Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	IDOV-SAFETM	Each patient received intratumoral injection on the first day, 14 days as a course of treatment, and the follow-up investigator decided whether to continue the second (D14) and third (D28) course of administration according to the comprehensive evaluation of the subjects' conditions

Timeline

• Start date: 2025-04-10
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2024-12-03
• Last updated: 2025-02-06