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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT03982303
Brief Summary:
This trial was a single-center, open-label, dose-increasing Phase I clinical study with subjects enrolled in patients with advanced solid tumors who failed standard treatment or who were unable to receive effective treatment. The trial is divided into two stages: dose escalation and dose extension.
Detailed Description:
Dose escalation:
A total of 7 dosage groups were set at this stage, which were 5 mg/m2, 10 mg/m2, 20 mg/m2, 40 mg/m2, 60 mg/m2, 90 mg/m2, and 120 mg/m2, respectively. Accelerated dosage titration was performed in the first 3 dose groups, 1 subject was enrolled in each group; the last 4 dose groups were perfromed into dosage groups by the principle of "3+3" dose increment rule, and the number of subjects enrolled in each group is 3 to 6 cases.
Dose extension:
According to the test results of the dose escalation phase, two extensions of MTD (tentative 60 mg/m2, 90 mg/m2) were selected for the expansion trial. Each dose level was planned to enroll 6 subjects (12 in total), subjects were administered once every 3 weeks (1 treatment cycle every 3 weeks), and received 4 treatment cycles in a row for Hemay102. Safety, tolerability, pharmacokinetic characteristics, and initial anti-tumor efficacy were evaluated.
Study:
NCT03982303
Study Brief:
Protocol Section:
NCT03982303