DAY101 for Low-grade Glioma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Low-grade Glioma+1 MoreDAY101 - Drug
Eligibility
6 - 25
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a BRAF inhibitor as a possible treatment for pediatric, adolescent, and young adult patients with cancer.

Eligible Conditions
  • Low-grade Glioma
  • Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 22 Secondary · Reporting Duration: Up to 48 months

Up to 48 months
Arm 1: Compare the response and time to progression following initiation of DAY101 to that of the prior line of systemic therapy
Upper arm
Arm 1: Overall response rate (ORR) by independent radiology review committee (IRC) based on RANO criteria
Arm 2: Assess the safety and tolerability of DAY101
Arm 3: Clinical benefit rate based on the proportion of patients with best overall response using RECIST v1.1 criteria
Arm 3: Determine the durability of response following discontinuation of DAY101 for patients with a radiographic response to DAY101 (CR or PR as based on RECIST v1.1 criteria) as determined by 1) an IRC and 2) the treating Investigator
Arm 3: Duration of response (DOR) with best overall response of CR or PR using RECIST v1.1 criteria by 1) an IRC and 2) the treating Investigator
Arm 3: Overall response rate (ORR) by independent radiology review committee (IRC) based on RECIST v1.1 criteria
Arm 3: Time to response following initiation of DAY101
Arms 1 & 2: Characterize changes in apparent diffusion coefficients following treatment with DAY101 using diffusion-weighted imaging analysis
Arms 1 & 2: Characterize changes in total tumor volume following treatment with DAY101 by magnetic resonance imaging (MRI) volumetric image analysis
Arms 1 & 2: Clinical benefit rate based on the proportion of patients with best overall response using RANO or RAPNO criteria
Arms 1 & 2: Describe the improvement in motor function compared with baseline
Arms 1 & 2: Determine the durability of response following discontinuation of DAY101 for patients with a radiographic response to DAY101
Arms 1 & 2: Duration of response (DOR) with best overall response of CR or PR using RANO and RAPNO criteria by 1) an IRC and 2) the treating Investigator (RANO only)
Upper arm
Arms 1 & 2: Progression free survival (PFS) using RANO and RAPNO criteria by 1) an IRC and 2) the treating Investigator (RANO only)
Arms 1 & 2: Time to response following initiation of DAY101
Arms 1 & 3: Assess the safety and tolerability of DAY101
Assess the safety and tolerability of DAY101
Characterize changes in apparent diffusion coefficients following treatment with DAY101 using diffusion-weighted imaging analysis
Characterize changes in total tumor volume following treatment with DAY101 by magnetic resonance imaging (MRI) volumetric image analysis
Clinical benefit rate based on the proportion of patients with best overall response
Compare the response and time to progression following initiation of DAY101 to that of the prior line of systemic therapy
Describe the improvement in motor function compared with baseline
Determine the durability of response following discontinuation of DAY101 for patients with a radiographic response to DAY101 (CR or PR as based on RANO and RAPNO criteria) as determined by 1) an IRC and 2) the treating Investigator
Duration of response (DOR) with best overall response of CR or PR using RANO and RAPNO criteria
Effect on electrocardiogram (ECG) and QT interval corrected for heart rate by Fridericia's formula (QTcF) prolongation
Evaluate changes from baseline in quality-of-life and health utilities measures using the Pediatrics Quality of Life™-Core Module (PedsQL-Core) and Patient-Reported Outcomes Measurement Information System (PROMIS®) assessment
Evaluate the concordance of prior local laboratory BRAF molecular profiling with a central BRAF alteration assay
Evaluate the concordance of prior local laboratory BRAF molecular profiling with a central BRAF alteration assay being evaluated by the Sponsor
Evaluate visual acuity (VA) outcomes compared with baseline
ORR by IRC and Investigator using RAPNO criteria
ORR by Investigator
ORR by Investigator using RANO criteria
Overall response rate (ORR) by independent radiology review committee (IRC) based on RANO criteria
Progression free survival (PFS) by IRC and Investigator using RANO and RAPNO criteria
Relationship between pharmacokinetics (PK) and drug effects
Time to response following initiation of DAY101

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

Single Arm
1 of 4
Arm #2
1 of 4
Arm #1
1 of 4
Arm #3
1 of 4

Experimental Treatment

140 Total Participants · 4 Treatment Groups

Primary Treatment: DAY101 · No Placebo Group · Phase 2

Single Arm
Drug
Experimental Group · 1 Intervention: DAY101 · Intervention Types: Drug
Arm #2
Drug
Experimental Group · 1 Intervention: DAY101 · Intervention Types: Drug
Arm #1
Drug
Experimental Group · 1 Intervention: DAY101 · Intervention Types: Drug
Arm #3
Drug
Experimental Group · 1 Intervention: DAY101 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 48 months

Who is running the clinical trial?

Day One Biopharmaceuticals, Inc.Lead Sponsor
4 Previous Clinical Trials
668 Total Patients Enrolled
2 Trials studying Low-grade Glioma
444 Patients Enrolled for Low-grade Glioma
Pacific Pediatric Neuro-Oncology ConsortiumOTHER
14 Previous Clinical Trials
655 Total Patients Enrolled
1 Trials studying Low-grade Glioma
44 Patients Enrolled for Low-grade Glioma

Eligibility Criteria

Age 6 - 25 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have LGG with documented BRAF alteration.
You have a solid tumor with documented known or expected to be activating RAF fusion.
The patient has a histopathologic diagnosis of LGG and a molecular diagnosis of BRAF alteration.
You have received at least one line of systemic therapy and have evidence of radiographic progression.