A Study of Dazostinag as Single Agent and Dazostinag in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors
Public ClinicalTrials.gov record NCT04420884. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label, Dose Escalation, Phase 1/2 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT04420884
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 248 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 21, 2020
- Primary completion
- Mar 29, 2026
- Completion
- Mar 29, 2026
- Last update posted
- Apr 7, 2026
2020 – 2026
United States locations
- U.S. sites
- 26
- U.S. states
- 15
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Diego Moores Cancer Center | La Jolla | California | 92093 | — |
| Norris Comprehensive Cancer Center | Los Angeles | California | 90089-1019 | — |
| UCI Health - Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| University of California Los Angeles - Jonsson Comprehensive Cancer Center | Santa Monica | California | 90404-2023 | — |
| SCRI - HealthOne Denver | Denver | Colorado | 80218-1238 | — |
| Yale Cancer Center | New Haven | Connecticut | 06519 | — |
| Memorial Cancer Institute at Memorial Hospital West - Cancer Institute/Radiology Oncology | Gainesville | Florida | 32610 | — |
| Robert H. Lurie Comprehensive Cancer Center of Northwestern University | Chicago | Illinois | 60611 | — |
| University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center | Detroit | Michigan | 48201 | — |
| Siteman Cancer Center - St. Peters | City of Saint Peters | Missouri | 63376 | — |
| Siteman Cancer Center - West County | Creve Coeur | Missouri | 63141 | — |
| Siteman Cancer Center - North County | Florissant | Missouri | 63031 | — |
| Washington University School of Medicine Siteman Cancer Center | St Louis | Missouri | 63110-1032 | — |
| Siteman Cancer Center - South County | St Louis | Missouri | 63129 | — |
| University of Cincinnati Health Barrett Cancer Center | Cincinnati | Ohio | 45019 | — |
| University of Cincinnati Health Barrett Cancer Center | Cincinnati | Ohio | 45219-2354 | — |
| West Chester Hospital | West Chester | Ohio | 45069 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Sarah Cannon Research Institute (SCRI) | Nashville | Tennessee | 37203 | — |
| Mary Crowley Cancer Research | Dallas | Texas | 75230 | — |
| Virginia Cancer Specialists, P.C. - Fairfax | Fairfax | Virginia | 22031-2171 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 36 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04420884, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 7, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04420884 live on ClinicalTrials.gov.