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Be Part of Research - Trial Details - A Study of Dazostinag as Single Agent and Dazostinag in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors

A Study of Dazostinag as Single Agent and Dazostinag in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The main aim of this study is to check if people with advanced solid tumors have side effects from dazostinag, and to check how much dazostinag they can receive without getting significant side effects from it when given alone and in combination with pembrolizumab. The study will be conducted in two phases including a dose escalation phase and a dose expansion phase. In the dose escalation phase, escalating doses of dazostinag are being tested alone and in combination with pembrolizumab to treat participants who have advanced or metastatic solid tumors. In the dose expansion phase, dazostinag will be studied with pembrolizumab with or without chemotherapy in participants with untreated metastatic or recurrent, unresectable squamous cell carcinoma of head and neck (SCCHN) and in combination with pembrolizumab in third-line or later recurrent locally advanced or metastatic microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) and third-line recurrent locally advanced or metastatic microsatellite stable/mismatch repair proficient (MSS/pMMR) colorectal cancer (CRC).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jul 2020 Jan 2026

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Dazostinag intravenous infusion.

Intervention Arm Group : Arm A: Japan Safety Lead-in Dazostinag + Pembrolizumab;Arm B: Japan Safety Lead-in Dazostinag Transitioned to Pembrolizumab;Part 1 (Monotherapy Dose Escalation Phase): Dazostinag Safety Lead-in + Dazostinag SA [Part 1A];Part 1B (Combination Dose Escalation Phase): Dazostinag + Pembrolizumab;Part 2A (SCCHN CPS ≥ 1 Dose Expansion and Optimization Phase): Dazostinag + Pembrolizumab;Part 2B (SCCHN Dose Expansion Phase): Dazostinag + Pembrolizumab + Chemotherapy;Part 3A (Expansion Phase in CRC): Dazostinag + Pembrolizumab in MSI-H/dMMR CRC;Part 3B (Expansion Phase in CRC): Dazostinag + Pembrolizumab in MSS/pMMR CRC;

Intervention Type : DRUG
Intervention Description : Pembrolizumab intravenous infusion.

Intervention Arm Group : Arm A: Japan Safety Lead-in Dazostinag + Pembrolizumab;Arm B: Japan Safety Lead-in Dazostinag Transitioned to Pembrolizumab;Part 1B (Combination Dose Escalation Phase): Dazostinag + Pembrolizumab;Part 2A (SCCHN CPS ≥ 1 Dose Expansion and Optimization Phase): Dazostinag + Pembrolizumab;Part 2B (SCCHN Dose Expansion Phase): Dazostinag + Pembrolizumab + Chemotherapy;Part 3A (Expansion Phase in CRC): Dazostinag + Pembrolizumab in MSI-H/dMMR CRC;Part 3B (Expansion Phase in CRC): Dazostinag + Pembrolizumab in MSS/pMMR CRC;

Intervention Type : DRUG
Intervention Description : Carboplatin or Cisplatin intravenous infusion

Intervention Arm Group : Part 2B (SCCHN Dose Expansion Phase): Dazostinag + Pembrolizumab + Chemotherapy;

Intervention Type : DRUG
Intervention Description : 5-fluorouracil intravenous infusion

Intervention Arm Group : Part 2B (SCCHN Dose Expansion Phase): Dazostinag + Pembrolizumab + Chemotherapy;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Queen's University Belfast
    Belfast
    Northern Ireland
    BT9 7BL
  • Oxford University Hospitals NHS Foundation Trust
    Oxford
    Ox1 2JD
  • Leeds Teaching Hospitals NHS Trust
    Leeds
    LS9 7TF
  • University College London Hospitals NHS Foundation Trust
    London
    NW1 2BU


The study is sponsored by Takeda




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Read full details for Trial ID: NCT04420884
Last updated 27 February 2025

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