NCT04306224

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

A First-in-Human, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of IMC-002 in Subjects With Metastatic or Locally Advanced Solid Tumors and Relapsed or Refractory Lymphomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: ImmuneOncia Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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. The study will consist of 2 parts: Part 1: Dose Escalation Part 2: Expansion Cohorts

Detailed description

Part 1: Dose Escalation 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.

Conditions

• Solid Tumor
• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	IMC-002	IMC-002 blocks the interaction between CD47 and SIRPα.

Timeline

• Start date: 2020-06-05
• Primary completion: 2022-10-07
• Completion: 2022-10-07
• First posted: 2020-03-12
• Last updated: 2024-04-12

Locations

4 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study