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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT06933069
Brief Summary:
This is a multicenter, open-lable phase Ia clinical study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary antitumor activity of CMAB017 in advanced malignant solid tumors.
Detailed Description:
This is a multicenter, open-lable, phase Ia study of CMAB017 which is planned to enroll about 55 patients with advanced solid tumors. The study is divided into the core period and the extension period.The core period involves the first four administrations of the drug, divided into two cohorts: the Q3W cohort (administering once every three weeks) and the Q2W cohort (administering once every two weeks). The pharmacokinetic profile and immunogenicity after completing dose escalation and observation for a total of four administrations are to be evaluated. In the extension period, for those subjects with therapeutic effects and tolerable side effects, the drug administration is to be prolonged. Further observations are to be made on the long-term safety, pharmacokinetic characteristics, immunogenicity, and anti-tumor effects of the treatment.
Study:
NCT06933069
Study Brief:
Protocol Section:
NCT06933069