NCT06718946

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

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 38 (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 Intravenous 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 17-32 patients with advanced solid tumors who have failed standard treatment in China to conduct intravenous administration of IDOV-SAFETM. This phase includes seven dose groups of 3x10\^8 PFU, 7x10\^8 PFU, 1x10\^9 PFU, 3x10\^9 PFU, 7x10\^9 PFU, 1x10\^10 PFU and 3x10\^10 PFU. The first dose group includes 1 subject. If the subject does not develop DLT, The next dose group should be opened for treatment. If this subject develops DLT, the dose group and all subsequent dose groups should be increased by the conventional "3+3" method. For the dose group with "3+3" dose increment, 3 to 6 subjects were enrolled in each group. Each patient received intravenous administration on the first day, with a course of 21 days. The follow-up investigator decided whether to continue the second (D22) 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: In the dose expansion phase, the previous dose or an intermediate dose of MTD and the clinical dosage to be used later were selected to carry out the expansion experiment, and 6 subjects were expanded. Each patient received intravenous administration on the first day, and the treatment course was 21 days. The follow-up researchers decided whether to continue the administration of the second course (D22) according to the comprehensive evaluation of the subjects' conditions. Each patient was treated for at least one course of treatment (22 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 (telephone survival follow-up every 8 weeks from the last dosing until the patient meets end-of-treatment criteria or end-of-survival follow-up date, whichever arrives first).

Conditions

• Advanced Malignant Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	IDOV-SAFE	Intravenous administration of oncolytic virus every 3 weeks until tumor progression

Timeline

• Start date: 2024-12-10
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2024-12-05
• Last updated: 2025-02-06

Locations

1 site across 1 country: China