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

Sponsor
ImmuneOncia Therapeutics Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03644056
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
25.8
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
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 :
Mar 22, 2018
Actual Primary Completion Date :
Feb 15, 2019
Actual Study Completion Date :
May 14, 2020

Arms and Interventions

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 Names:
  • Not confirm yet

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Occurrence of DLTs [During the first 21 days of treatment]

      To investigate the occurrence of DLTs of IMC-001 treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ImmuneOncia Yongin-si Gyeonggi-do Korea, Republic of 17084

    Sponsors and Collaborators

    • ImmuneOncia Therapeutics Inc.

    Investigators

    • Study Director: Yun Jeong Song, CMO/CEO, ImmuneOncia Therapeutics Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ImmuneOncia Therapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT03644056
    Other Study ID Numbers:
    • IMC-001-101
    First Posted:
    Aug 23, 2018
    Last Update Posted:
    May 28, 2020
    Last Verified:
    May 1, 2020
    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
    Additional relevant MeSH terms:
    Neoplasms
    Neoplasm Metastasis

    Study Results

    No Results Posted as of May 28, 2020