NCT03644056

Dose-escalation Study of IMC-001 in Subject With Metastatic or Locally-advanced Solid Tumors

A Phase 1, Open-label, Multiple-ascending Dose Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of IMC-001 in Subjects With Metastatic or Locally-advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: ImmuneOncia Therapeutics Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1, Open-label, Multiple-ascending Dose Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of IMC-001 in Subjects with Metastatic or Locally-advanced Solid Tumors

Detailed description

IMC-001 is a PD-L1 targeting, fully human monoclonal antibody. The purpose of this study is to determine safety and evaluate PK, PD and clinical activity of IMC-001. Multiple dose levels of IMC-001 will be tested in subjects with metastatic or locally-advanced solid tumors. Data from this study will also help determine the recommended phase 2 dose of IMC-001.

Conditions

• Solid Tumor
• Metastasis
• Locally Advanced

Interventions

Type	Name	Description
DRUG	IMC-001	Different IMC-001 dose level for each cohort group (IMC-001 2 mg/kg etc. every 2 weeks)

Timeline

• Start date: 2018-03-22
• Primary completion: 2019-02-15
• Completion: 2020-05-14
• First posted: 2018-08-23
• Last updated: 2020-05-28

Locations

1 site across 1 country: South Korea