NCT05565417

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Immunitas Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Non Small Cell Lung Cancer
• Head and Neck Squamous Cell Carcinoma
• Triple Negative Breast Cancer
• Cutaneous Squamous Cell Carcinoma
• Hormone Receptor Positive Breast Carcinoma
• Small Bowel Cancer
• Esophageal Cancer
• Colorectal Cancer
• Diffuse Large B Cell Lymphoma
• Hodgkin Lymphoma
• Burkitt Lymphoma
• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	IMT-009	Participants will receive an IV infusion of IMT-009 on Day 1 during each 21-day cycle.
COMBINATION_PRODUCT	Fruquintinib	Fruquintinib will be administered according to the FDA-approved United States Prescribing Information (USPI).

Timeline

• Start date: 2022-11-28
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2022-10-04
• Last updated: 2025-10-16

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study