Trial | NCT03644056  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    15
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
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.
Study Started
Mar 22
2018
Primary Completion
Feb 15
2019
Study Completion
May 14
2020
Last Update
May 28
2020

Drug IMC-001

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

  • Other names: Not confirm yet

IMC-001 Experimental

Multiple Dose Level (IMC-001 2 mg/kg etc. every 2 weeks)

Criteria 

Inclusion Criteria:

Signed Informed Consent Form (ICF).
Adult (19 years or older).
Histologically or cytologically proven metastatic or locally-advanced solid tumors

Exclusion Criteria:

Treatment with non-permitted drugs (within the past 28 days of Screening), including but not limited to systemic immunosuppressive agents, any other investigational medicinal product (IMP), anti-coagulant, or live vaccines.
Any prior cancer immunotherapy
Concurrent anticancer treatments
No Results Posted