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Clinical Trial Summary

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


Clinical Trial Description

The study is a single agent dose escalation which will use an accelerated and "3+3" design to evaluate escalating doses of IDOV-SAFETM.Total enrollment will depend on the toxicities and/or activity observed, with approximately 13-19 evaluable participants enrolled. A Dose-Limiting Toxicity (DLT) observation period of 3weeks was established before the entry of the first patient at the next dose level. After all subjects in the current dose group have completed the DLT observation period, the administration of the next dose group can only be started if the condition of dose escalation is met. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06346041
Study type Interventional
Source Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact Ning Li, MD
Phone 15601395554
Email lining@cicams.ac.cn
Status Recruiting
Phase Early Phase 1
Start date April 12, 2024
Completion date April 1, 2026

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