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 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT07182435
Brief Summary:
This is a Phase 1 clinical study investigating RH125 as monotherapy or in combination therapy in patients with locally advanced or metastatic solid tumors who failed standard treatment, or were intolerant to standard treatment, or declined standard treatment. The aim of the study is to evaluate the tolerability, safety, immunogenicity, and preliminary efficacy of RH125 monotherapy or combination with PD-1 blocker.
Detailed Description:
This study will be divided into monotherapy dose escalation and combination therapy dose escalation phases. Each phase requires the enrollment of 12-18 subjects, with a total of 24-36 subjects to be enrolled in the entire study. Both the monotherapy dose escalation and combination therapy dose escalation will involve 3 dose levels, which are 100 μg, 150 μg, and 200 μg respectively. A "3+3" design will be adopted, and the Dose-Limiting Toxicity (DLT) observation period will be 21 days for both phases.
Study:
NCT07182435
Study Brief:
Protocol Section:
NCT07182435