TAK-676 as Single Agent and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors

• Research type

  Research Study

• Full title

  An Open-label, Dose Escalation, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-676 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced or Metastatic Solid Tumors

• IRAS ID

  1006372

• Contact name

  Takeda Contact Takeda Contact

• Contact email

  medinfoUS@takeda.com

• Sponsor organisation

  Takeda Development Center Americas, Inc. (TDC Americas)

• Eudract number

  2022-000528-39

• Clinicaltrials.gov Identifier

  NCT04420884

• Research summary

  The purpose of this study is to determine if the experimental investigational medicinal product (IMP) TAK-676 is effective when used with another medication called pembrolizumab with or without standard chemotherapy. This is to treat a type of advanced head and neck cancer that did not resolve with radiation or surgery alone and has not yet been treated separately with systemic medications (can affect the entire body) or because previously treated advanced colorectal cancer (CRC) does not respond to treatment.

  The main purposes of Parts 2 and 3 of the study are to evaluate the safety and tolerability of TAK-676 in combination with pembrolizumab with or without chemotherapy in participants with advanced head and neck cancer and evaluate the safety and tolerability of TAK-676 in combination with pembrolizumab in participants with advanced CRC.

  This study will also confirm the safe and effective dose(s) of TAK-676 that will be used in combination with pembrolizumab with or without chemotherapy, measure the concentration levels of TAK-676 given in combination with pembrolizumab with or without chemotherapy (known as pharmacokinetic or “PK” measurements), evaluate whether and how well the participant's disease is responding to the study medications, and determine the effect of TAK-676 on the immune system.

  The total amount of time the participant may be involved in the study is up to 24 months. There will be about 174 patients taking part in Parts 2 and 3 of this study at approximately 60 study clinics in North America and Europe.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  23/YH/0022

• Date of REC Opinion

  21 Mar 2023

• REC opinion

  Further Information Favourable Opinion