NCT03644056

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2020

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

11 months

First QC Date

August 17, 2018

Last Update Submit

May 26, 2020

Conditions

Solid TumorMetastasisLocally Advanced

Keywords

IMC-001

Outcome Measures

Primary Outcomes (1)

  • Occurrence of DLTs

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

    During the first 21 days of treatment

Study Arms (1)

IMC-001

EXPERIMENTAL

Multiple Dose Level (IMC-001 2 mg/kg etc. every 2 weeks)

Drug: IMC-001

Interventions

IMC-001DRUG

Different IMC-001 dose level for each cohort group (IMC-001 2 mg/kg etc. every 2 weeks)

Also known as: Not confirm yet
IMC-001

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed Informed Consent Form (ICF).
  • Adult (19 years or older).
  • Histologically or cytologically proven metastatic or locally-advanced solid tumors

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ImmuneOncia

Yongin-si, Gyeonggi-do, 17084, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 34268711DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

IMC-001

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yun Jeong Song, CMO/CEO

    ImmuneOncia Therapeutics Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2018

First Posted

August 23, 2018

Study Start

March 22, 2018

Primary Completion

February 15, 2019

Study Completion

May 14, 2020

Last Updated

May 28, 2020

Record last verified: 2020-05

Locations

KR(1)