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

NCT04478461 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-11-13

No results posted yet for this study

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.

Conditions

  • Advanced Solid Tumor

Interventions

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

Sponsors & Collaborators

  • Mabwell (Shanghai) Bioscience Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Suxia Luo, professor · Henan Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-03
Primary Completion
2023-01-05
Completion
2023-02-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04478461 on ClinicalTrials.gov