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

May 26, 2020 updated by: ImmuneOncia Therapeutics Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Yongin-si, Gyeonggi-do, Korea, Republic of, 17084
        • ImmuneOncia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of DLTs
Time Frame: During the first 21 days of treatment
To investigate the occurrence of DLTs of IMC-001 treatment.
During the first 21 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImmuneOncia Therapeutics Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 22, 2018

Primary Completion (ACTUAL)

February 15, 2019

Study Completion (ACTUAL)

May 14, 2020

Study Registration Dates

First Submitted

August 17, 2018

First Submitted That Met QC Criteria

August 21, 2018

First Posted (ACTUAL)

August 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMC-001-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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