Last updated on August 2020

A Study of IMC-002 in Subjects With Metastatic or Locally Advanced Solid Tumors and Relapsed or Refractory Lymphomas

Brief description of study

This is the first-in-human, Phase I, open-label, multiple-ascending dose study to investigate the safety, tolerability, PK, PharmDyn, and clinical activity of IMC-002 in subjects with metastatic or locally advanced solid tumors and relapsed or refractory lymphomas.

Male or female subjects 18 years and older with metastatic or locally advanced solid tumors and relapsed or refractory lymphomas will be included in the study if they meet all the inclusion criteria and none of the exclusion criteria.

After providing informed consent, subjects will be assessed for study eligibility during the Screening period (Day -28 to Day -1).

The study will consist of 2 parts:

Part 1: Dose Escalation Part 2: Expansion Cohorts

Detailed Study Description

Part 1: Dose Escalation Dose escalation will follow the traditional 3+3 design. Cohorts of 3 subjects will be given escalating doses of IMC-002 once every 2 weeks as an IV infusion over 60 minutes. Dose-limiting toxicities (DLT) will be assessed during the 28-day DLT evaluation period. The decision to escalate to the next dose level will be based on safety assessments after all subjects of a cohort have reached Day 28 (DLT evaluation period).

Part 2: Expansion Cohort The study may be amended in the future to include expansion cohorts in selected tumor types to further evaluate extended safety of IMC-002 at recommended Phase 2 dose in that tumor type. Sample size in the Dose Expansion part will be determined when the study is amended to include the expansion cohorts.

Clinical Study Identifier: NCT04306224

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Recruitment Status: Open

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