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

ImmuneOncia Therapeutics

Status and phase: Completed; Phase 1

Conditions: Solid Tumor; Locally Advanced; Metastasis

Treatments: Drug: IMC-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT03644056

IMC-001-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

IMC-001

Experimental group

Description:

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

Treatment:

Drug: IMC-001