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

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ClinicalTrials.gov Identifier: NCT03644056
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
ImmuneOncia Therapeutics Inc.

Brief 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

Condition or disease Intervention/treatment Phase
Solid Tumor Metastasis Locally Advanced Drug: IMC-001 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : March 22, 2018
Estimated Primary Completion Date : November 29, 2019
Estimated Study Completion Date : December 27, 2019

Arm Intervention/treatment
Experimental: IMC-001
Multiple Dose Level (IMC-001 2 mg/kg etc. every 2 weeks)
Drug: IMC-001
Different IMC-001 dose level for each cohort group (IMC-001 2 mg/kg etc. every 2 weeks)
Other Name: Not confirm yet




Primary Outcome Measures :
  1. Occurrence of DLTs [ Time Frame: During the first 21 days of treatment ]
    To investigate the occurrence of DLTs of IMC-001 treatment.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Any prior cancer immunotherapy
  3. Concurrent anticancer treatments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644056


Contacts
Contact: HyeonJu Kim, aCPL +82 31 306 8151 hjkim@immuneoncia.com

Locations
Korea, Republic of
ImmuneOncia Recruiting
Yongin-si, Gyeonggi-do, Korea, Republic of, 17084
Contact: HyeonJu Kim, aCPL         
Sponsors and Collaborators
ImmuneOncia Therapeutics Inc.
Investigators
Study Director: Yun Jeong Song, CMO/CEO ImmuneOncia Therapeutics Inc.

Responsible Party: ImmuneOncia Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03644056     History of Changes
Other Study ID Numbers: IMC-001-101
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ImmuneOncia Therapeutics Inc.:
IMC-001