Dose-escalation Study of IMC-001 in Subject With Metastat... | NCT03644056

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

NCT03644056

Sponsor

ImmuneOncia Therapeutics Inc.

Status

Completed

Last Update Posted

May 28, 2020Actual

Enrollment

15Actual

Phase

Phase 1

Conditions

Solid Tumor
Metastasis
Locally Advanced

Interventions

IMC-001

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 22, 2018Actual

Primary Completion Date

Feb 15, 2019Actual

Completion Date

May 14, 2020Actual

First Submitted Date

Aug 17, 2018

First Submission Date that Met QC Criteria

Aug 21, 2018

First Posted Date

Aug 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2020

Last Update Posted Date

May 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IMC-001	Experimental	Multiple Dose Level (IMC-001 2 mg/kg etc. every 2 weeks)	Drug: IMC-001

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IMC-001	Drug	Different IMC-001 dose level for each cohort group (IMC-001 2 mg/kg etc. every 2 weeks)	IMC-001

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yun Jeong Song, CMO/CEO	ImmuneOncia Therapeutics Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ImmuneOncia		Yongin-si	Gyeonggi-do	17084	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34268711	Derived	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.

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms