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Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas

Colorectal Cancer Clinical Trial

Official title:
A Phase 1/2a, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas

Clinical Trial Summary

This is a Phase 1/2a open-label, multicenter, dose escalation and dose expansion trial in which IMT-009 will be administered by the intravenous (IV) route to participants with solid tumors or lymphomas. The main goals of this study are to: - Find the recommended dose of IMT-009 that can be safely given to participants - Learn more about the side effects of IMT-009 - Learn more about pharmacokinetics of IMT-009 - Learn more about the effectiveness of IMT-009 - Learn more about different pharmacokinetic biomarkers and how they might change in the presence of IMT-009

Clinical Trial Description

IMT-009 is an Fc-attenuated monoclonal antibody that binds with high affinity and selectivity to CD161, a receptor that is broadly expressed on NK and a subset of memory T cells, blocking interactions between the receptor and its cognate ligand, CLEC2D, which is expressed on the surface of both cancer cells and immune cells. Preclinical data confirm that CD161 blockade with IMT-009 results in enhanced anti-tumor activity. This is a Phase 1/2a, open label dose escalation study of IMT-009, a fully human monoclonal antibody targeting CD161, given as a single agent in Phase 1 and potentially in combination with other antineoplastic agents in Phase 2. ;

Study Design

Related Conditions & MeSH terms

  • Breast Neoplasms
  • Burkitt Lymphoma
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Colorectal Cancer
  • Colorectal Neoplasms
  • Cutaneous Squamous Cell Carcinoma
  • Diffuse Large B Cell Lymphoma
  • Esophageal Cancer
  • Esophageal Neoplasms
  • Follicular Lymphoma
  • Head and Neck Squamous Cell Carcinoma
  • Hodgkin Disease
  • Hodgkin Lymphoma
  • Hormone Receptor Positive Breast Carcinoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Non Small Cell Lung Cancer
  • Small Bowel Cancer
  • Squamous Cell Carcinoma of Head and Neck
  • Triple Negative Breast Cancer
  • Triple Negative Breast Neoplasms
Clinical Trial Details
NCT number NCT05565417
Study type Interventional
Source Immunitas Therapeutics
Contact Immunitas Therapeutics
Phone 781.996.0564
Email CTInformation@immuntastx.com
Status Recruiting
Phase Phase 1/Phase 2
Start date November 28, 2022
Completion date April 2025
View Details
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