A Clinical Study of 8MW2311 in Subjects With Locally Advanced or Metastatic Solid Tumors
NCT05416749 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 216
Last updated 2024-11-20
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
Interventions
- DRUG
-
8MW2311
All subjects will receive a single intravenous (IV) infusion of 8MW2311 every 21 days (q21d), other dosing frequencies may be used.
Sponsors & Collaborators
-
Mabwell (Shanghai) Bioscience Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jian Zhang · Fudan University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-05
- Primary Completion
- 2026-03-31
- Completion
- 2026-03-31
Countries
- China
Study Locations
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