Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT06054932
Brief Summary:
This is an open-labeled, single-center phase I study in patients with incurable advanced solid tumors, who failed with all previous standard therapy. The aim is to observe and evaluate the safety, tolerability, and immunogenicity of LK101 injection.
Detailed Description:
This study is designed to evaluate the safety, tolerability, and immunogenicity of the dose escalation of LK101. We used the traditional "3+3" dose escalation design, Subjects who have been pathologically diagnosed with advanced solid tumors and defined as failing all previous standard therapy. LK101 will be administered in a prime-boost schedule of 4 priming vaccination followed by 3 booster vaccinations. The dose escalation will be conducted in a sequential manner, enrolled patients were initially placed in cohort 1, in which the priming phase is administered at 2-week intervals. And then followed the next cohort 2, where the priming phase is administered at 1-week intervals. Decisions with regard to dose escalation to the next dose level will be made jointly by the investigators and the sponsor. AE data was collected until the 21 days following the last prime dose. safety and immunogenicity will also be used to inform the final dose and schedule. A minimum of 6 patients will be treated at the MTD/RP2D.
Study:
NCT06054932
Study Brief:
Protocol Section:
NCT06054932