NCT05416749

A Clinical Study of 8MW2311 in Subjects With Locally Advanced or Metastatic Solid Tumors

Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of 8MW2311 in Subjects With Locally Advanced or Metastatic Solid Tumors

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase 1/2, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary antitumor activity and immunogenicity of 8MW2311 administered by intravenous (IV) infusion.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	8MW2311	All subjects will receive a single intravenous (IV) infusion of 8MW2311 every 21 days (q21d), other dosing frequencies may be used.

Timeline

• Start date: 2022-08-05
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2022-06-13
• Last updated: 2024-11-20

Locations

3 sites across 1 country: China