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

Phase 1

Completed

• Conditions: Solid Tumor; Locally Advanced; Metastasis
• Interventions: Drug: IMC-001

• Registration Number: NCT03644056
• Lead Sponsor: ImmuneOncia Therapeutics Inc.

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.

Study Timeline

• Study Start: 2018-03-22
• Study First Submitted: 2018-08-17
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-23
• Primary Completion: 2019-02-15
• Status Verified: 2020-05
• Study Completion: 2020-05-14
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Occurrence of DLTs	During the first 21 days of treatment	To investigate the occurrence of DLTs of IMC-001 treatment.

Trial Locations

Locations (1)

ImmuneOncia; 🇰🇷 Yongin-si, Gyeonggi-do, Korea, Republic of