Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04775485 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors
A Phase 2 study of Advanced Solid Tumor and Low Grade Glioma, sponsored by Day One Biopharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 141
- Enrollment target
- 20
- Study locations
NCT04775485: Recruiting Phase 2 study of Advanced Solid Tumor and Low Grade Glioma, sponsored by Day One Biopharmaceuticals.
NCT04775485 is a Phase 2 study of Advanced Solid Tumor and Low Grade Glioma that is actively recruiting participants, run by Day One Biopharmaceuticals. The registered enrollment target is 141 participants, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (27% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04775485, a Phase 2 study of Advanced Solid Tumor and Low Grade Glioma, is actively recruiting participants, sponsored by Day One Biopharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 141 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of Type II RAF (tovorafenib) in pediatric participants with low-grade glioma or advanced solid tumors. Qualifying genomic alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories prior to enrollment into any of the arms. The study will consist of a screening period, a treatment period, a long-term extension phase, end of treatment (EOT) visit(s), a safety follow-up visit, and long-term follow-up assessments.
Primary Outcome
ORR is defined as percentage of participants with best overall confirmed response of complete response (CR) or partial response (PR) by the Response Assessment in Neuro-Oncology - high-grade glioma (RANO-HGG) criteria.
Conditions Studied
Interventions
- DRUG Tovorafenib
Study Locations (20)
Other
- Queensland Children's Hospital - Brisbane
- Royal Children's Hospital - Parkville
- Perth Children's Hospital - Perth
- Sydney Children's Hospital - Randwick
- The Children's Hospital at Westmead - Westmead
California
- UCSF Benioff Children's Hospital - San Francisco
District of Columbia
- Children's National Medical Center - Washington D.C.
Illinois
- Lurie Children's Hospital of Chicago - Chicago
Maryland
- Johns Hopkins Hospital - Baltimore
Massachusetts
- Dana-Farber Cancer Institute - Boston
Michigan
- CS Mott Children's Hospital - Ann Arbor
Missouri
- St. Louis Children's Hospital - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2021-04-22 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 2 |
What NCT04775485 shows while recruiting
NCT04775485 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (27% lower).
The record links to 2 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which Tovorafenib is the first listed.
NCT04775485 names 20 study sites across 16 states, led by Other, California, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT04775485 about?
NCT04775485 is a clinical study titled "A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors". This is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of Type II RAF (tovorafenib) in pediatric participants with low-grade glioma or advanced solid tumors. Qualifying genomic alterations will be identified through molecular assays as routinely performed at Clinical L...
What is the current status of trial NCT04775485?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 141 participants. The study started on 2021-04-22. Estimated completion is 2027-05-31.
What conditions does trial NCT04775485 study?
This clinical trial studies the following conditions: Advanced Solid Tumor, Low Grade Glioma.
What interventions are being tested in trial NCT04775485?
The interventions under investigation include: Tovorafenib (DRUG).
Who is sponsoring clinical trial NCT04775485?
This trial is sponsored by Day One Biopharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04775485 being conducted?
This trial has 20 study locations across California, District of Columbia, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04775485's enrollment target sits among peer trials
141 94th of 189 higher than 95 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor 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
-
A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01)
RECRUITING · Phase 2
-
A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
RECRUITING · Phase 2
-
Study of Rituximab or Tocilizumab for Patients With Steroid-Dependent Immune-Related Adverse Events (irAEs)
ACTIVE NOT RECRUITING · Phase 2
-
A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations
ACTIVE NOT RECRUITING · Phase 2
-
Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors
COMPLETED · Phase 2
-
PM14 Administered Intravenously to Patients with Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03042962 · 141 participants
Brain Networks in Dystonia
- NCT04378439 · 141 participants · NA
Appalachian Partnership to Reduce Disparities (Aim 2)
- NCT05040360 · 141 participants · Phase 2
Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors
- NCT05814146 · 141 participants · NA
Trial of Variable Dialysate Bicarbonate
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI