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A Study of MSB2311 in Advanced Solid Tumors

NCT04272944 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-12-18

No results posted yet for this study

Summary

This is a first-in-human (FIH), open-label, Phase 1 dose-Escalation Study of MSB2311, a humanized anti-PD-L1 monoclonal antibody, in subjects with advanced solid tumors. Qualified subjects will be enrolled to receive their assigned dose regimen of MSB2311 until disease progression or intolerable toxicity, withdrawal of consent, or end of study, whichever occurs first. The maximum treatment duration is 2 years. During the study, subjects will be evaluated for safety and toxicity, PK/PD, immunogenicity and anti-tumor activity of MSB2311.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

10 mg/kg Q2W

10 mg/kg MSB2311 every two weeks

DRUG

20 mg/kg Q3W

20 mg/kg MSB2311 every three weeks.

Sponsors & Collaborators

  • Suzhou Transcenta Therapeutics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Mengde Wang · Suzhou Transcenta Therapeutics Co., Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-08-13
Primary Completion
2022-01-31
Completion
2022-01-31
FDA Drug
Yes

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 NCT04272944 on ClinicalTrials.gov