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

NCT03644056 — Phase 1, Completed, 15 participants, ImmuneOncia Therapeutics Inc.

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT03644056
Status	Completed
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, other
Enrollment	15 (Actual)
Sponsor	ImmuneOncia Therapeutics Inc. (Industry)
Conditions	Solid Tumor, Metastasis, Locally Advanced
Interventions	IMC-001 (Drug)
Dates	start 2018-03-22, primary completion 2019-02-15, completion 2020-05-14, first posted 2018-08-23, last updated 2020-05-28
Locations	1 site in South Korea

-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

Expand all sections · Collapse all

+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.

+Arms and interventions

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

IMC-001 (Drug), also known as Not confirm yet: Different IMC-001 dose level for each cohort group (IMC-001 2 mg/kg etc. every 2 weeks)

+Outcome measures

Primary outcomes

Occurrence of DLTs [During the first 21 days of treatment]: To investigate the occurrence of DLTs of IMC-001 treatment.

+Eligibility

Sex: All, ages: 19 Years to any

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

+Locations (1)

Facility	City	Country	Status
ImmuneOncia	Yongin-si, Gyeonggi-do	South Korea

+Publications

Results publication: 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 34268711

+Investigators

Yun Jeong Song, CMO/CEO, Study director, ImmuneOncia Therapeutics Inc.

My Notes

Public

To Read Reading Read