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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07416695
Brief Summary:
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX3901 in patients with Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma.
Detailed Description:
phase Ia is the dose escalation and backfill stage, accelerated titration and 3 + 3 dose escalation method will be adopted in the dose escalation stag, and the patients will be administered with HLX3901 at different doses via intravenous infusion. The DLT observation period lasts for 4 weeks after the first administration of HLX3901. The backfill cohort will enrolls 2 to 3 dose groups.
Part Ib is a dose-expansion study of HLX3901, designed to explore and confirm the efficacy and safety of HLX3901 monotherapy in advanced small-cell lung cancer or neuroendocrine carcinoma.The Safety Review Committee will recommend dose groups for expansion based on the safety, efficacy and PK data of the dose escalation phase.
Study:
NCT07416695
Study Brief:
Protocol Section:
NCT07416695