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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-22

Study Completion Date

2020-05-14

Brief Summary

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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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Detailed Description

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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.

Conditions

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Solid Tumor Metastasis Locally Advanced

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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IMC-001

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

Group Type EXPERIMENTAL

IMC-001

Intervention Type DRUG

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

Interventions

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IMC-001

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

Intervention Type DRUG

Other Intervention Names

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Not confirm yet

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No