deltatrials
Recruiting PHASE2 INTERVENTIONAL 3-arm NCT04775485

A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors (FIREFLY-1)

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

Sponsor: Day One Biopharmaceuticals, Inc.

Interventions Tovorafenib
Updated 14 times since 2021 Last updated: Mar 27, 2025 Started: Apr 22, 2021 Primary completion: May 31, 2027 Completion: May 31, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Advanced Solid Tumor and Low-grade Glioma, this trial is actively recruiting participants. The trial is conducted by Day One Biopharmaceuticals, Inc. and has accumulated 14 data snapshots since 2021. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Mar 2021 – ~Jun 2021 · 3 months · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshot~Dec 2021 – ~Jun 2022 · 6 months · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Nov 2022 · 4 months · monthly snapshot~Nov 2022 – ~Feb 2023 · 3 months · monthly snapshot~Feb 2023 – ~Dec 2023 · 10 months · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~May 2025 · 8 months · monthly snapshot~May 2025 – ~Sep 2025 · 4 months · monthly snapshot~Sep 2025 – present · 9 months · monthly snapshot

Change History

14 versions recorded
  1. Sep 2025 — Present [monthly]

    Recruiting PHASE2

  2. May 2025 — Sep 2025 [monthly]

    Recruiting PHASE2

  3. Sep 2024 — May 2025 [monthly]

    Recruiting PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE2

  5. Jan 2024 — Jul 2024 [monthly]

    Recruiting PHASE2

Show 9 earlier versions
  1. Dec 2023 — Jan 2024 [monthly]

    Recruiting PHASE2

  2. Feb 2023 — Dec 2023 [monthly]

    Recruiting PHASE2

  3. Nov 2022 — Feb 2023 [monthly]

    Recruiting PHASE2

  4. Jul 2022 — Nov 2022 [monthly]

    Recruiting PHASE2

  5. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE2

  6. Dec 2021 — Jun 2022 [monthly]

    Recruiting PHASE2

  7. Sep 2021 — Dec 2021 [monthly]

    Recruiting PHASE2

  8. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE2

    Status: Not Yet RecruitingRecruiting

  9. Mar 2021 — Jun 2021 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Day One Biopharmaceuticals, Inc.
  • Pacific Pediatric Neuro-Oncology Consortium
Data source: Day One Biopharmaceuticals, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .