Low-grade GliomaPhase 2FIREFLY-1NCT04775485
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 testing Tovorafenib in people with Low-grade Glioma and Advanced Solid Tumor, run by Day One Biopharmaceuticals, Inc. at 35 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 25 years
- Conditions the study is for
- Low-grade Glioma, Advanced Solid Tumor
- What is being tested?
- Tovorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 35 sitesin 11 countries
- Study dates
- 22 Apr 2021to 31 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Low Grade Glioma \& Low-Grade Glioma Extension: a relapsed or progressive LGG with documented known activating BRAF alteration.
- Advanced Solid Tumor: locally advanced or metastatic solid tumor with documented known or expected to be activating RAF fusion.
- Participants must have histopathologic verification of malignancy at either original diagnosis or relapse.
- Must have received at least one line of prior systemic therapy and have documented evidence of radiographic progression.
- Must have at least 1 measurable lesion as defined by RANO (Arms 1 \& 2) or RECIST v1.1 (Arm 3) criteria
Who cannot join
- Participant's tumor has additional previously-known activating molecular alterations.
- Participant has symptoms of without radiographically recurrent or radiographically progressive disease.
- Known or suspected diagnosis of neurofibromatosis type 1 (NF-1) via genetic testing or current diagnostic criteria.
- Other inclusion/exclusion criteria as stipulated by protocol may apply
Trial locations and contacts
35 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
35 sites in 11 countries
United States14 sites, 12 recruiting
- Recruiting
CS Mott Children's Hospital
Ann Arbor, Michigan, 48109
- Terminated
Johns Hopkins Hospital
Baltimore, Maryland, 21231
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
- Recruiting
Duke Cancer Center
Durham, North Carolina, 27710
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
- Recruiting
NYU Langone Health
New York, New York, 10016
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
- Terminated
Doernbecher Children's Hospital Oregon & Health Science University
Portland, Oregon, 97239
- Recruiting
University of Utah
Salt Lake City, Utah, 84113
- Recruiting
UCSF Benioff Children's Hospital
San Francisco, California, 94143
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
- Recruiting
St. Louis Children's Hospital
St Louis, Missouri, 63110
- Recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20010
braintumorresearch@childrensnational.org, 202-476-5000
Australia5 sites, 5 recruiting
- Recruiting
Queensland Children's Hospital
Brisbane, 4101
- Recruiting
Royal Children's Hospital
Parkville, 3052
- Recruiting
Perth Children's Hospital
Perth, WA 6009
- Recruiting
Sydney Children's Hospital
Randwick, NSW 2031
- Recruiting
The Children's Hospital at Westmead
Westmead, 2145
Canada3 sites, 3 recruiting
- Recruiting
Centre Hospitalier Universitaire Ste-Justine
Montreal, Quebec, H3T 1C5
- Recruiting
Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
- Recruiting
Centre Mère-Enfant Soleil du CHU
Québec, Quebec, G1V 4G2
Israel3 sites, 3 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, 3109601
- Recruiting
Schneider Children's Medical Center of Israel
Petah Tikva, 4920235
- Recruiting
The Chaim Sheba Medical Center
Ramat Gan, 5265601
Germany2 sites, 2 recruiting
- Recruiting
Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Otto-Heubner-Centrum für Kinder
Berlin, 13353
- Recruiting
Hopp-Kindertumorzentrum Heidelberg (KiTZ), KiTZ Clinical Trial Unit (ZIPO)
Heidelberg, 69120
South Korea2 sites, 2 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 3080
- Recruiting
Severance Hospital - Yonsei University
Seoul, 3722
United Kingdom2 sites, 2 recruiting
- Recruiting
UCL Great Ormond Street Institute of Child Health
London, WC1N 1EH
- Recruiting
Newcastle University
Newcastle upon Tyne, NE1 7RU
Netherlands1 site, 1 recruiting
- Recruiting
Princess Maxima Center for Pediatric Oncology
Utrecht, 3584 CS
Singapore1 site, 1 recruiting
- Recruiting
KK Women's and Children's Hospital
Singapore, 229899
Switzerland1 site, 1 recruiting
- Recruiting
Universitäts-Kinderspital Zürich - Eleonorenstiftung
Zurich, 8032
About this study
Official title: FIREFLY-1: A Phase 2, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients With RAF-Altered, Recurrent or Progressive Low-Grade Glioma and Advanced 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 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.
- Conditions
- Low-grade Glioma, Advanced Solid Tumor
- Being tested
- Tovorafenib
- Keywords
- Low-grade Glioma, Advanced Solid Tumor, FIREFLY-1, DAY101, Tovorafenib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TovorafenibDrug
Also called DAY101
Tovorafenib is an oral Type II RAF kinase inhibitor available in 100 mg immediate-release tablet or 25 mg/milliliter (mL) powder for reconstitution.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Low-Grade Glioma | Experimental | Participants with recurrent or progressive low-grade glioma will receive 420 milligrams/meters square (mg/m^2) of tovorafenib weekly according to dose rounding guidelines and according to their baseline body surface area (BSA). Receives: Drug: Tovorafenib |
| Arm 2: Low-Grade Glioma Expanded Access | Experimental | Participants with recurrent or progressive low-grade glioma will receive 420 mg/m^2 of tovorafenib weekly according to dose rounding guidelines and according to their baseline BSA. Receives: Drug: Tovorafenib |
| Arm 3: Advanced Solid Tumor | Experimental | Participants with advanced solid tumors will receive 420 mg/m^2) of tovorafenib weekly according to dose rounding guidelines and according to their baseline BSA. Receives: Drug: Tovorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm 1: Overall response rate
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.
Measured: Up to 48 months
Arm 2: Number of participants reporting adverse events
An adverse event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to 48 months
Arm 2: Number of participants with clinically significant changes in clinical chemistry parameters
Measured: Up to 48 months
Arm 2: Number of participants with clinically significant changes in hematology parameters
Measured: Up to 48 months
Arm 3: Overall response rate
Determined by the treating investigator and measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or RANO-HGG criteria, as appropriate.
Measured: Up to 48 months
Secondary outcomes (19)
Arm 1 and 3: Number of participants reporting adverse events
An adverse event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to 48 months
Arm 1 and 3: Number of participants with clinically significant changes in clinical chemistry parameters
Measured: Up to 48 months
Arm 1 and 3: Number of participants with clinically significant changes in hematology parameters
Measured: Up to 48 months
Arm 1: Area under the concentration-time curve (AUC) of Tovorafenib
Measured: Cycle 1: Day 1 and Day 15; Cycles 2, 4, 7, 10 and 13: Day 1
Arm 1: Minimum drug concentration (Cmin)
Measured: Cycle 1: Day 1 and Day 15; Cycles 2, 4, 7, 10 and 13: Day 1
Arm 1: Change from Baseline QT interval corrected for heart rate by Fridericia's formula (ΔQTcF)
Measured: Baseline to 48 months
Arm 1: Change from Baseline PR interval (ΔPR)
Measured: Baseline to 48 months
Arm 1: Change from Baseline QRS interval (ΔQRS)
Measured: Baseline to 48 months
Arm 1: Change from baseline heart rate (ΔHR)
Measured: Baseline to 48 months
Arm 1: Change in electrocardiogram (ECG) waveform morphology
Measured: Baseline to 48 months
Arm 1 and Arm 2: Overall response rate
ORR is defined as percentage of participants with best overall confirmed response of CR or PR by the RANO-HGG criteria.
Measured: Up to 48 months
Arm 1, Arm 2 and Arm 3: Overall response rate in Pediatric participants
ORR is defined as percentage of participants with best overall confirmed response of CR or PR or minor response (MR) by Response Assessment in Pediatric Neuro-Oncology (RAPNO) criteria.CR or PR by RECIST v1.1 criteria.
Measured: Up to 48 months
Arm 1, Arm 2 and Arm 3: duration of progression-free survival (PFS)
PFS as defined by the time following initiation of tovorafenib to progression or death in participants treated with tovorafenib measured by RECIST v1.1, RAPNO, or RANO-HGG criteria as determined by the treating investigator and an IRC.
Measured: Up to 48 months
Arm 1, Arm 2 and Arm 3: Duration of response (DOR)
DOR as defined by the length of response in participants with best overall confirmed response of CR or PR or MR and measured by RANO-HGG, RAPNO, and/or RECIST v1.1 criteria, as applicable.
Measured: Up to 48 months
Arm 1, Arm 2 and Arm 3: Time to response (TTR)
TTR as defined as the time to first response following initiation of tovorafenib in participants with best overall confirmed response of CR or PR measured by RECIST v1.1 or RANO-HGG criteria, as applicable.
Measured: Up to 48 months
Arm 1, Arm 2 and Arm 3: Clinical benefit rate (CBR)
CBR as defined as participants with BOR of CR, PR or stable disease (SD) measured by RECIST v1.1 or RANO-HGG, as applicable, and lasting 12 months or more following initiation of tovorafenib.
Measured: Up to 48 months
Arm 1 and Arm 2: Duration of overall survival
Overall survival as defined by the time following initiation of tovorafenib to death of any cause in participants treated with tovorafenib.
Measured: Up to 48 months
Arm 1: Change from baseline in best corrected visual acuity (BCVA) outcomes
Measured: Baseline to 48 months
Arm 1: Changes in molecular analysis of cells obtained from archival tissue
Measured: At Screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start22 Apr 2021
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low-grade GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Day One Biopharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pacific Pediatric Neuro-Oncology Consortium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775485
- Sponsor's protocol ID
- DAY101-001/PNOC026
- Acronym
- FIREFLY-1
- Status last verified
- Mar 2025
- First submitted
- 3 Feb 2021
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kilburn LB, Khuong-Quang DA, Hansford JR, Landi D, van der Lugt J, Leary SES, Driever PH, Bailey S, Perreault S, McCowage G, Waanders AJ, Ziegler DS, Witt O, Baxter PA, Kang HJ, Hassall TE, Han JW, Hargrave D, Franson AT, Yalon Oren M, Toledano H, Larouche V, Kline C, Abdelbaki MS, Jabado N, Gottardo NG, Gerber NU, Whipple NS, Segal D, Chi SN, Oren L, Tan EEK, Mueller S, Cornelio I, McLeod L, Zhao X, Walter A, Da Costa D, Manley P, Blackman SC, Packer RJ, Nysom K. The type II RAF inhibitor tovorafenib in relapsed/refractory pediatric low-grade glioma: the phase 2 FIREFLY-1 trial. Nat Med. 2024 Jan;30(1):207-217. doi: 10.1038/s41591-023-02668-y. Epub 2023 Nov 17.
PubMed 37978284
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIREFLY-1: A Phase 2, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients With RAF-Altered, Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04775485
- Acronym / sponsor ID
- FIREFLY-1 / DAY101-001/PNOC026
- Conditions
- Low-grade Glioma, Advanced Solid Tumor
- Keywords
- Low-grade Glioma, Advanced Solid Tumor, FIREFLY-1, DAY101, Tovorafenib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- Day One Biopharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pacific Pediatric Neuro-Oncology Consortium
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Low-Grade Glioma | Experimental | Drug: TovorafenibParticipants with recurrent or progressive low-grade glioma will receive 420 milligrams/meters square (mg/m^2) of tovorafenib weekly according to dose rounding guidelines and according to their baseline body surface area (BSA). |
| Arm 2: Low-Grade Glioma Expanded Access | Experimental | Drug: TovorafenibParticipants with recurrent or progressive low-grade glioma will receive 420 mg/m^2 of tovorafenib weekly according to dose rounding guidelines and according to their baseline BSA. |
| Arm 3: Advanced Solid Tumor | Experimental | Drug: TovorafenibParticipants with advanced solid tumors will receive 420 mg/m^2) of tovorafenib weekly according to dose rounding guidelines and according to their baseline BSA. |
Who may qualify
- Ages
- 6 months to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Low Grade Glioma \& Low-Grade Glioma Extension: a relapsed or progressive LGG with documented known activating BRAF alteration.
- Advanced Solid Tumor: locally advanced or metastatic solid tumor with documented known or expected to be activating RAF fusion.
- Participants must have histopathologic verification of malignancy at either original diagnosis or relapse.
- Must have received at least one line of prior systemic therapy and have documented evidence of radiographic progression.
- Must have at least 1 measurable lesion as defined by RANO (Arms 1 \& 2) or RECIST v1.1 (Arm 3) criteria
Key exclusion criteria (4 listed)
- Participant's tumor has additional previously-known activating molecular alterations.
- Participant has symptoms of without radiographically recurrent or radiographically progressive disease.
- Known or suspected diagnosis of neurofibromatosis type 1 (NF-1) via genetic testing or current diagnostic criteria.
- Other inclusion/exclusion criteria as stipulated by protocol may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TovorafenibAlso: DAY101Tovorafenib is an oral Type II RAF kinase inhibitor available in 100 mg immediate-release tablet or 25 mg/milliliter (mL) powder for reconstitution. | Drug | Arm 1: Low-Grade Glioma, Arm 2: Low-Grade Glioma Expanded Access, Arm 3: Advanced Solid Tumor |
Primary outcome
Arm 1: Overall response rate
Time frame: Up to 48 months
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.
Arm 2: Number of participants reporting adverse events
Time frame: Up to 48 months
An adverse event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Arm 2: Number of participants with clinically significant changes in clinical chemistry parameters
Time frame: Up to 48 months
Arm 2: Number of participants with clinically significant changes in hematology parameters
Time frame: Up to 48 months
Arm 3: Overall response rate
Time frame: Up to 48 months
Determined by the treating investigator and measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or RANO-HGG criteria, as appropriate.
19 secondary outcomes
Arm 1 and 3: Number of participants reporting adverse events
Time frame: Up to 48 months
Arm 1 and 3: Number of participants with clinically significant changes in clinical chemistry parameters
Time frame: Up to 48 months
Arm 1 and 3: Number of participants with clinically significant changes in hematology parameters
Time frame: Up to 48 months
Arm 1: Area under the concentration-time curve (AUC) of Tovorafenib
Time frame: Cycle 1: Day 1 and Day 15; Cycles 2, 4, 7, 10 and 13: Day 1
Arm 1: Minimum drug concentration (Cmin)
Time frame: Cycle 1: Day 1 and Day 15; Cycles 2, 4, 7, 10 and 13: Day 1
Arm 1: Change from Baseline QT interval corrected for heart rate by Fridericia's formula (ΔQTcF)
Time frame: Baseline to 48 months
Arm 1: Change from Baseline PR interval (ΔPR)
Time frame: Baseline to 48 months
Arm 1: Change from Baseline QRS interval (ΔQRS)
Time frame: Baseline to 48 months
Arm 1: Change from baseline heart rate (ΔHR)
Time frame: Baseline to 48 months
Arm 1: Change in electrocardiogram (ECG) waveform morphology
Time frame: Baseline to 48 months
Arm 1 and Arm 2: Overall response rate
Time frame: Up to 48 months
Arm 1, Arm 2 and Arm 3: Overall response rate in Pediatric participants
Time frame: Up to 48 months
Arm 1, Arm 2 and Arm 3: duration of progression-free survival (PFS)
Time frame: Up to 48 months
Arm 1, Arm 2 and Arm 3: Duration of response (DOR)
Time frame: Up to 48 months
Arm 1, Arm 2 and Arm 3: Time to response (TTR)
Time frame: Up to 48 months
Arm 1, Arm 2 and Arm 3: Clinical benefit rate (CBR)
Time frame: Up to 48 months
Arm 1 and Arm 2: Duration of overall survival
Time frame: Up to 48 months
Arm 1: Change from baseline in best corrected visual acuity (BCVA) outcomes
Time frame: Baseline to 48 months
Arm 1: Changes in molecular analysis of cells obtained from archival tissue
Time frame: At Screening
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Derived from this study: PubMed 37978284Kilburn LB, Khuong-Quang DA, Hansford JR, Landi D, van der Lugt J, Leary SES, Driever PH, Bailey S, Perreault S, McCowage G, Waanders AJ, Ziegler DS, Witt O, Baxter PA, Kang HJ, Hassall TE, Han JW, Hargrave D, Franson AT, Yalon Oren M, Toledano H, Larouche V, Kline C, Abdelbaki MS, Jabado N, Gottardo NG, Gerber NU, Whipple NS, Segal D, Chi SN, Oren L, Tan EEK, Mueller S, Cornelio I, McLeod L, Zhao X, Walter A, Da Costa D, Manley P, Blackman SC, Packer RJ, Nysom K. The type II RAF inhibitor tovorafenib in relapsed/refractory pediatric low-grade glioma: the phase 2 FIREFLY-1 trial. Nat Med. 2024 Jan;30(1):207-217. doi: 10.1038/s41591-023-02668-y. Epub 2023 Nov 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
35 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tovorafenib in people with Low-grade Glioma and Advanced Solid Tumor, run by Day One Biopharmaceuticals, Inc. at 35 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Australia, Canada, Israel, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Day One Biopharmaceuticals, Inc. (650-484-0899, firefly-1@dayonebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arm 1: Overall response rate (time frame: Up to 48 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04775485, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.