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

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03644056
• Other study ID #: IMC-001-101
• Status: Completed
• Phase: Phase 1
• Start date: March 22, 2018
• Est. completion date: May 14, 2020

Study information

• Verified date: May 2020
• Source: ImmuneOncia Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 14, 2020
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced
• Metastasis
• Neoplasm Metastasis
• Neoplasms
• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	ImmuneOncia	Yongin-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
ImmuneOncia Therapeutics Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of DLTs	To investigate the occurrence of DLTs of IMC-001 treatment.	During the first 21 days of treatment