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+ Years
All
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?
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.
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.
For more information, view the full study details:
NCT044208842022-000528-39U1111-1241-4427jRCT2031230532