NCT04844073

A Study of TAK-186 (Also Known as MVC-101) in Adults With Advanced or Metastatic Cancer

A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-186 (Also Known as MVC-101), An EGFR x CD3 COnditional Bispecific Redirected Activation (COBRA) Protein in Patients With Unresectable Locally Advanced or Metastatic Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to check for side effects and tolerability of TAK-186 (also known as MVC-101) in adults with unremovable advanced or metastatic cancer. Another aim is to characterize and evaluate the activity of TAK-186 (MVC-101). Participants may receive treatment throughout the study for a maximum of 13 months and will be followed up at 30 days and 90 days and then every 12 weeks for up to 48 weeks after the last treatment.

Detailed description

This Phase 1/2, open-label study will characterize safety and dose-limiting toxicities (DLTs) of TAK-186. Dose escalation will occur in participants with advanced solid tumors. A Cohort Expansion Phase will be enrolled to further characterize safety and initial anti-tumor activity in participants with solid tumors expressing epidermal growth factor receptor (EGFR), including HNSCC, CRC or NSCLC.

Conditions

• Squamous Cell Cancer of Head and Neck (SCCHN)
• Non-small Cell Lung Cancer (NSCLC)
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	TAK-186	TAK-186 IV infusion.

Timeline

• Start date: 2021-03-08
• Primary completion: 2025-06-17
• Completion: 2025-06-17
• First posted: 2021-04-14
• Last updated: 2025-12-04

Locations

27 sites across 4 countries: United States, Australia, South Korea, United Kingdom

Regulatory

• FDA-regulated drug study