TAK-186 in patients with unresectable locally advanced or metastatic cancer
Research type
Research Study
Full title
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
IRAS ID
1008695
Contact name
Pingkuan Zhang
Contact email
Sponsor organisation
Takeda Development Center Americas, Inc.
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to determine the safety and tolerability of TAK-186, and to find the appropriate dose of TAK-186 to be used for cancer patients in future studies. The dose escalation phase will find the recommended doses of TAK-186. The cohort expansion phase will investigate the side effects of the doses determined in the dose escalation phase in patients with HNSCC (head and neck cancer), NSCLC (lung cancer) or CRC (colorectal cancer).
TAK-186 is an antibody (a special kind of protein) being developed as a cancer treatment. It is thought to work by attaching to cancer cells and certain types of immune cells (T-cells) at the same time. TAK-186 is designed to activate T-cells, helping the body’s immune system kill cancer cells. This study is the first time that TAK-186 has been given to humans. As of March 2023, 20 patients have received TAK-186.
Patients aged 18 or older with certain cancer types that cannot be removed by surgery or that have spread may be suitable for this study. Approximately 228 patients will take part worldwide with approximately 8 patients from 4 hospitals in the UK.
The total study duration will be up to approximately 28 months (4 weeks screening; 55 weeks treatment; a visit 30 days after the last dose of TAK-186; and then contact every 12 weeks for up to 48 weeks). The first cycle will last 7 weeks, and subsequent cycles will last 8 weeks. Patients will visit the site 7-8 times during each cycle, and TAK-186 will be administered by intravenous infusion weekly. Study procedures include physical examination, vital signs, ECGs, blood and urine samples, tumour assessment by CT or MRI scan, tumour biopsies and TAK-186 administration.
This study is sponsored by Takeda Development Center Americas, Inc.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
23/EE/0236
Date of REC Opinion
14 Nov 2023
REC opinion
Further Information Favourable Opinion