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 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT07021066
Brief Summary:
The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid Tumors.
Detailed Description:
This is a multicenter Phase 1, open-label study to evaluate the safety, tolerability, pharmacokinetic profile, and initial efficacy of BL-M05D1 in subjects with unresectable locally advanced or metastatic solid tumors that are known to potentially express CLDN18.2 as defined below that have recurred or progressed on at least 1 line of prior systemic therapy (including adjuvant/neoadjuvant), have no other standard of care options, and have no available curative options.
This study will be conducted in three parts (dose escalation, dose finding and dose expansion). Subjects will be dosed on Day 1 on a continuous 21-day treatment cycle.
Study:
NCT07021066
Study Brief:
Protocol Section:
NCT07021066