Safety, Tolerability, and Pharmacokinetics of MW11 in Patients With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title: A Phase Ia Clinical Trial to Assess Safety, Tolerability, and Pharmacokinetics of a Recombinant Humanized Anti-PD-1 Monoclonal Antibody (MW11) for Injection in Patients With Advanced Solid Tumors

Status Recruiting

Clinical Trial Summary

This is a phase Ia, single-center, open label, dose escalation clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and anti-tumor efficacy of MW11 (a recombinant humanized anti-PD-1 monoclonal antibody) for injection in patients with advanced solid tumors.

Clinical Trial Description

The enrollment mainly depends on "3+3" principle. A total of 3 or 4 dose groups will be evaluated during the dose escalation period: 1, 3, 10 mg/kg, and maybe an additional fixed dose (e.g., to evaluate 200 mg or other fixed dose as RP2D). The drug is scheduled to be administrated Q3W. Actual dose increments or dosing frequency may be adjusted according to PK data and safety of MW11. Safety, tolerability, and DLT will be assessed within 3 weeks (21 days) after initial administration. Anti-tumor efficacy will be assessed every 6 weeks during the first 24 weeks and every 12 weeks ever since. The study will be divided into screening period and treatment period. The drug administration will be continued until the investigators consider that the subjects will no longer benefit from the treatment, or the subjects meet intolerable toxicity, or the subjects withdraw the informed consent, or disease progression occurs. ;

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

• NCT number: NCT04478461
• Study type: Interventional
• Source: Mabwell (Shanghai) Bioscience Co., Ltd.
• Contact: Shan An
• Phone: 13613865536
• Email: watermelonas@163.com
• Status: Recruiting
• Phase: Phase 1
• Start date: September 3, 2020
• Completion date: February 2, 2023