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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

About this trial

This is an interventional other trial for Solid Tumor focused on measuring IMC-001

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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