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A Phase I Study of MSB2311 in Advanced Solid Tumors

NCT03463473 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-12-18

No results posted yet for this study

Summary

This is a phase I study to determine the safety and toxicity, PK/PD, immunogenicity, biomarkers, anti-tumor activity and establish a preliminary recommended Phase 2 dose (RP2D) in subjects with advanced solid tumors.

Conditions

Interventions

DRUG

3 mg/kg Q3W MSB2311 Injection

An intravenous infusion with concentration from 3 mg/kg (Q3W)

DRUG

10 mg/kg Q3W MSB2311 Injection

An intravenous infusion with concentration from 10 mg/kg (Q3W)

DRUG

20 mg/kg Q3W MSB2311 Injection

An intravenous infusion with concentration from 20 mg/kg (Q3W)

DRUG

10 mg/kg Q2W MSB2311 Injection

An intravenous infusion with concentration from 10 mg/kg (Q2W)

Sponsors & Collaborators

  • Suzhou Transcenta Therapeutics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yonggang Wu, MD · Suzhou Transcenta Therapeutics Co., Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-12
Primary Completion
2020-06-01
Completion
2020-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03463473 on ClinicalTrials.gov