Dose-escalation Study of IMC-001 in Subject With Metastatic or Locally-advanced Solid Tumors
Primary Purpose
Solid Tumor, Metastasis, Locally Advanced
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
IMC-001
Sponsored by
About this trial
This is an interventional other trial for Solid Tumor focused on measuring IMC-001
Eligibility 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
Sites / Locations
- ImmuneOncia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IMC-001
Arm Description
Multiple Dose Level (IMC-001 2 mg/kg etc. every 2 weeks)
Outcomes
Primary Outcome Measures
Occurrence of DLTs
To investigate the occurrence of DLTs of IMC-001 treatment.
Secondary Outcome Measures
Full Information
NCT ID
NCT03644056
First Posted
August 17, 2018
Last Updated
May 26, 2020
Sponsor
ImmuneOncia Therapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03644056
Brief Title
Dose-escalation Study of IMC-001 in Subject With Metastatic or Locally-advanced Solid Tumors
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 22, 2018 (Actual)
Primary Completion Date
February 15, 2019 (Actual)
Study Completion Date
May 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmuneOncia Therapeutics Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Metastasis, Locally Advanced
Keywords
IMC-001
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMC-001
Arm Type
Experimental
Arm Description
Multiple Dose Level (IMC-001 2 mg/kg etc. every 2 weeks)
Intervention Type
Drug
Intervention Name(s)
IMC-001
Other Intervention Name(s)
Not confirm yet
Intervention Description
Different IMC-001 dose level for each cohort group (IMC-001 2 mg/kg etc. every 2 weeks)
Primary Outcome Measure Information:
Title
Occurrence of DLTs
Description
To investigate the occurrence of DLTs of IMC-001 treatment.
Time Frame
During the first 21 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun Jeong Song, CMO/CEO
Organizational Affiliation
ImmuneOncia Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
ImmuneOncia
City
Yongin-si
State/Province
Gyeonggi-do
ZIP/Postal Code
17084
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
34268711
Citation
Keam B, Ock CY, Kim TM, Oh DY, Kang WK, Park YH, Lee J, Lee JH, Ahn YH, Kim HJ, Chang SK, Park J, Choi JY, Song YJ, Park YS. A phase I study of IMC-001, a PD-L1 blocker, in patients with metastatic or locally advanced solid tumors. Invest New Drugs. 2021 Dec;39(6):1624-1632. doi: 10.1007/s10637-021-01078-6. Epub 2021 Jul 16.
Results Reference
derived
Learn more about this trial
Dose-escalation Study of IMC-001 in Subject With Metastatic or Locally-advanced Solid Tumors
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