Locally Advanced, Metastasis, Solid Tumor
Conditions
Keywords
IMC-001
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.
Interventions
DRUGIMC-001
Different IMC-001 dose level for each cohort group (IMC-001 2 mg/kg etc. every 2 weeks)
Sponsors
ImmuneOncia Therapeutics Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of DLTs | During the first 21 days of treatment | To investigate the occurrence of DLTs of IMC-001 treatment. |
Countries
South Korea
Outcome results
None listed