NCT04478461

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

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: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	PD-1 monoclonal antibody	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

Timeline

• Start date: 2020-09-03
• Primary completion: 2023-01-05
• Completion: 2023-02-02
• First posted: 2020-07-20
• Last updated: 2020-11-13

Locations

1 site across 1 country: China