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

Sponsored by Takeda

About this trial

Last updated 3 months ago

Study ID

TAK-676-1002

Status

Active, not recruiting

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 5 years ago

What is this trial about?

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).

What are the participation requirements?

Yes

Inclusion Criteria

Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Must have adequate bone marrow, renal, hepatic and cardiac functions.
No

Exclusion Criteria

Cannot have been treated with other stimulator of interferon genes (STING) agonists/antagonist and toll-like receptors agonists within the past 6 months.
Cannot be a recipient of allogeneic or autologous stem cell transplantation or organ transplantation.

Additional entry criteria will be discussed with the study doctor.

Locations

Location

Status

For more information, view the full study details:

NCT044208842022-000528-39U1111-1241-4427jRCT2031230532