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

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

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Key information

Conditions

Solid Tumor Locally Advanced Metastasis Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ImmuneOncia

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMC-001

Drug

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

Other names: Not confirm yet

Primary outcomes

Occurrence of DLTs

Time frame: During the first 21 days of treatment

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

Sponsors and collaborators

Lead sponsor

ImmuneOncia Therapeutics Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2020
First posted: Aug 23, 2018
Registry last updated: May 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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