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NCT04420884 · ClinicalTrials.gov registry record · Phase 1
A Study of Dazostinag as Single Agent and Dazostinag in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors
A Phase 1 study of Solid Neoplasms, sponsored by Takeda.
- Active
- Registry status
- Phase 1
- Development phase
- 248
- Enrollment target
- 20
- Study locations
NCT04420884: Active Phase 1 study of Solid Neoplasms, sponsored by Takeda.
NCT04420884 is a Phase 1 study of Solid Neoplasms that is active but no longer recruiting, run by Takeda. The registered enrollment target is 248 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (313% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04420884, a Phase 1 study of Solid Neoplasms, is active but no longer recruiting, sponsored by Takeda.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 248 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
A severity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Grade 1 scales as Mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 scales as Moderate (minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living \[ADL\]); Grade 3 scales as Severe (severe or medically significant but not immediately life t
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG 5-fluorouracil
- DRUG Platinum
- DRUG Dazostinag
Study Locations (20)
Missouri
- Siteman Cancer Center - St. Peters - City of Saint Peters
- Siteman Cancer Center - West County - Creve Coeur
- Siteman Cancer Center - North County - Florissant
- Washington University School of Medicine Siteman Cancer Center - St Louis
- Siteman Cancer Center - South County - St Louis
California
- University of California San Diego Moores Cancer Center - La Jolla
- Norris Comprehensive Cancer Center - Los Angeles
- UCI Health - Chao Family Comprehensive Cancer Center - Orange
- University of California Los Angeles - Jonsson Comprehensive Cancer Center - Santa Monica
Ohio
- University of Cincinnati Health Barrett Cancer Center - Cincinnati
- University of Cincinnati Health Barrett Cancer Center - Cincinnati
- West Chester Hospital - West Chester
Massachusetts
- Massachusetts General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Colorado
- SCRI - HealthOne Denver - Denver
Connecticut
- Yale Cancer Center - New Haven
Florida
- Memorial Cancer Institute at Memorial Hospital West - Cancer Institute/Radiology Oncology - Gainesville
Illinois
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2020-07-22 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 1 |
What the registry record for NCT04420884 still lists
NCT04420884 is an interventional study that assigns participants to a tested intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (313% higher).
The record links to 1 condition, with Solid Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT04420884 names 20 study sites across 10 states, led by Missouri, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT04420884 about?
NCT04420884 is a clinical study titled "A Study of Dazostinag as Single Agent and Dazostinag in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors". 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...
What is the current status of trial NCT04420884?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 248 participants. The study started on 2020-07-22. Estimated completion is 2026-03-31.
What conditions does trial NCT04420884 study?
This clinical trial studies the following conditions: Solid Neoplasms.
What interventions are being tested in trial NCT04420884?
The interventions under investigation include: Pembrolizumab (DRUG), 5-fluorouracil (DRUG), Platinum (DRUG), Dazostinag (DRUG).
Who is sponsoring clinical trial NCT04420884?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04420884 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04420884's enrollment target sits among peer trials
248 185th of 2000 higher than 1,814 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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