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

ImmuneOncia Therapeutics Inc.15 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Solid Tumor Metastasis Locally Advanced

Interventions

IMC-001DRUG

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

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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)

ImmuneOncia

Yongin-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Occurrence of DLTs

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

Time frame: During the first 21 days of treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.