At a glance
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Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of Injectable BL-M02D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors or Other Solid Tumors
In Brief
A Phase 1 clinical trial evaluating BL-M02D1 for Locally Advanced or Metastatic Digestive Tract Tumors and Solid Tumor. Active but no longer recruiting, targeting 22 participants across 1 site.
Detailed Summary
In phase Ia study, the safety and tolerability of BL-M02D1 in patients with locally advanced or metastatic gastroenteric tumor or other solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-M02D1. In phase Ib study, the safety and tolerability of BL-M02D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined. In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-M02D1 in patients with locally advanced or metastatic gastroenteric tumor or other solid tumors will be evaluated.
Study Details
Timeline
Interventions
Administration by intravenous infusion